Identity
- Trade Name
- Entuit FDA UDI
- Generic Name
- Gastrostomy T fastener FDA UDI
- Device Name
- Entuit Secure Adjustable Gastrointestinal Suture Anchor Set FDA UDI
- Model / Reference
- G35562 FDA UDI
- Description
- Entuit Secure Adjustable Gastrointestinal Suture Anchor Set FDA UDI
Identifiers
- Catalog Number
- GIAS-SRM-ADJ-2 FDA UDI
- Primary DI / UDI-DI
- 00827002355620 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Gastrostomy T fastener FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Gastrostomy T fastener
Entuit by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrostomy T fastener.
- Entuit — COOK INCORPORATED · Class II
- Cope — COOK INCORPORATED · Class II
- Cope — COOK INCORPORATED · Class II
- Cope — COOK INCORPORATED · Class II
- Entuit — COOK INCORPORATED · Class II
- Entuit — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI 55962d4b-1c8a-4260-a7db-7568bc46e5ca 36 fields · synced Jun 8, 2026