Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Haemostasis valve FDA UDI
- Device Name
- Tuohy-Borst Side-Arm Adapter FDA UDI
- Model / Reference
- G06299 FDA UDI
- Description
- Tuohy-Borst Side-Arm Adapter FDA UDI
Identifiers
- Catalog Number
- PTBYC-RA FDA UDI
- Primary DI / UDI-DI
- 00827002062993 FDA UDI
- FDA Product Code
- KGZ FDA UDI
- GMDN Term
- Haemostasis valve FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Haemostasis valve
Cook by Cook Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemostasis valve.
- AccessPLUS™ — Merit Medical Systems, Inc. · Class II
- FLO30™ — Merit Medical Systems, Inc. · Class II
- VSI Micro-HV Introducer Kit — Galt Medical Corp. · Class II
- GUARDIAN — TELEFLEX INCORPORATED · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- Honor® — Merit Medical Systems, Inc. · Class II
- AVANTI — Cordis Corp. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI d4329b1f-586e-478d-9e33-11ba43916499 36 fields · synced Jun 8, 2026