Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Fascial tissue dilator, reusable FDA UDI
- Device Name
- Tunneling Device FDA UDI
- Model / Reference
- G02677 FDA UDI
- Description
- Tunneling Device FDA UDI
Identifiers
- Catalog Number
- TD-1 FDA UDI
- Primary DI / UDI-DI
- 00827002026773 FDA UDI
- FDA Product Code
- KDC FDA UDI
- GMDN Term
- Fascial tissue dilator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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: Fascial tissue dilator, reusable
Cook by Cook Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fascial tissue dilator, reusable.
- VADER Pedicle System, Dilator Navigated, Ø 20.5 mm — Icotec · Class II
- ReLine — Nuvasive, Inc. · Class II
- ReLine — Nuvasive, Inc. · Class I
- ReLine — Nuvasive, Inc. · Class II
- Precept — Nuvasive, Inc. · Class II
- MIP Minimal Invasive PCNL — Karl Storz GmbH & Co. KG · Class II
- Facet Fixation — SeaSpine Orthopedics Corporation · Class I
- Facet Fixation — SeaSpine Orthopedics Corporation · Class I
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 49650b86-4bb4-45c2-83c7-781a81b23db4 36 fields · synced Jun 8, 2026