Identity
- Trade Name
- ISI FDA UDI
- Generic Name
- Upper-limb traction wrap/trap, reusable FDA UDI
- Device Name
- Pkg of 2 - S Hooks for Traction Set FDA UDI
- Model / Reference
- S-Hooks FDA UDI
- Description
- Pkg of 2 - S Hooks for Traction Set FDA UDI
Identifiers
- Catalog Number
- K3270 FDA UDI
- Primary DI / UDI-DI
- 00810045921631 FDA UDI
- FDA Product Code
- ILZ FDA UDI
- GMDN Term
- Upper-limb traction wrap/trap, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5925 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
Yes
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Upper-limb traction wrap/trap, reusable
Isi by Instrument Specialists, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Upper-limb traction wrap/trap, reusable.
- Ambler Surgical — Ambler Surgical, LLC · Class II
- TRAPS, FINGER, DOUBLE, 5/PK — AliMed, LLC · Class I
- INFLATABLE CUFF/STRAP ASSEMBLY — Mizuho Orthopedic Systems, Inc. · Class I
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class II
- TRAPS, FINGER, SINGLES, 5/PK — AliMed, LLC · Class I
- FINGER TRAP SET (5), ADULT, LITEGRIP — Mizuho Orthopedic Systems, Inc. · Class I
- Ambler Surgical — Ambler Surgical, LLC · 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 |
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Manufacturer
- Manufacturer
- Instrument Specialists, Inc.
Sources (1)
- FDA UDI fb2179a1-0e71-448f-b1bd-78fa66f83183 34 fields · synced Jun 1, 2026