DRAP REGISTERED MEDICAL DEVICE
Hi-Torque Cross-IT Guide Wire with Hydrocoat Hydrophilic Coating is registered with DRAP under number MDIR-0000140 as a Class D (high risk) medical device, imported. The listed holder is Digital Imaging Systems. Its listed renewal date (26 Feb 2024) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0000140
DRAP registered Class B/C/D list, 28 Aug 2025
It may have been renewed after DRAP's last list. Ask the vendor for the renewal letter.
ELI-00094
| Device | Hi-Torque Cross-IT Guide Wire with Hydrocoat Hydrophilic Coating |
|---|---|
| Class | D |
| Listed holder | Digital Imaging Systems |
| Holder address | 121- Habitat Apartments, Shadman II, Ghaus-ul-Azam Road, Lahore, Godown: Same as above |
| Manufacturing site | M/s Abbott Vascular 3200 Lakeside Drive, Santa Clara, CA 95054, USA M/s Abbott Vascular Road # 2, km 58.0, Cruce Davila, Barceloneta, PR 00617, USA M/s Abbott Vascular 26531, Ynez Rd., Temecula, CA 92591, USA |
| Issued | 27 Feb 2019 |
| Renewal date | 26 Feb 2024 |
| Licence | ELI-00094 |
Specifications
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Screened 5 Oct 2026, 02:27 (Pakistan time). A screening aid, not an official DRAP verification.
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| MDIR-0000010 | NC Trek RX Coronary Dilatation Catheter | Class D |
| MDIR-0000011 | Mini Trek RX Coronary Dilatation Catheter | Class D |
| MDIR-0000012 | Trek RX Coronary Dilatation Catheter | Class D |
| MDIR-0000013 | RX Herculink Elite Peripheral Stent System | Class C |
| MDIR-0000014 | RX Acculink Carotid Stent System | Class D |
| MDIR-0000015 | Omnilink Elite Peripheral Stent System | Class C |
| MDIR-0000016 | Hi-Torque Whisper Guide Wire with Hydrophilic Coating | Class D |
| MDIR-0000017 | Hi-Torque Balance Middle Weight Guide Wire | Class D |
Corrections
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Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.