Identity
- Trade Name
- Integra® Jarit® FDA UDI
- Generic Name
- Eye muscle hook, reusable FDA UDI
- Device Name
- Integra® Jarit® Jameson Muscle Hook, 5", 9.2mm Hook, 1.4mm Tip FDA UDI
- Model / Reference
- 350353 FDA UDI
- Description
- Integra® Jarit® Jameson Muscle Hook, 5", 9.2mm Hook, 1.4mm Tip FDA UDI
Identifiers
- Catalog Number
- 350-353 FDA UDI
- Primary DI / UDI-DI
- 10381780195382 FDA UDI
- FDA Product Code
- HNQ FDA UDI
- GMDN Term
- Eye muscle hook, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Eye muscle hook, reusable
Integra® Jarit® by Integra LifeSciences Production Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eye muscle hook, reusable.
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Muscle Hook — SONTEC INSTRUMENTS, INC. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Scobee Oblique Muscle Hook, 4.5mm — AURORA SURGICAL, LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · 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
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI 08d995f9-7c64-48a1-8c44-7d584a617cd1 35 fields · synced Jun 9, 2026