Identity
- Trade Name
- Coulmed FDA UDI
- Generic Name
- Operating table patient positioning set, reusable FDA UDI
- Device Name
- Pediatric Gel Padded Ankle Straps for Candy Cane Stirrups, Size: 3/8' x 1-7/8' x 12-1/2', per pair FDA UDI
- Model / Reference
- GP159-5 FDA UDI
- Description
- Pediatric Gel Padded Ankle Straps for Candy Cane Stirrups, Size: 3/8' x 1-7/8' x 12-1/2', per pair FDA UDI
Identifiers
- Catalog Number
- GP159-5 FDA UDI
- Primary DI / UDI-DI
- 10810087351110 FDA UDI
- FDA Product Code
- PRN FDA UDI
- GMDN Term
- Operating table patient positioning set, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5680 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
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: Operating table patient positioning set, reusable
Coulmed by Coulmed Products Group Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Operating table patient positioning set, reusable.
- Mindray — Nanjing Mindray Bio-Medical Electronics Co., Ltd · Class I
- Skytron — Skytron, LLC · Class I
- FusionMAX — SURGIX MEDICAL LLC · Class I
- Bariatric Table Extensions, Full Set of 8 with 2" Pads, 24" Leg Section — Composite Manufacturing, Inc. · Class I
- Mindray — Nanjing Mindray Bio-Medical Electronics Co., Ltd · Class I
- Bariatric Table Extension 2" Pads, Full Set of 8 — Composite Manufacturing, Inc. · Class I
- Mindray — Nanjing Mindray Bio-Medical Electronics Co., Ltd · Class I
- Schaerer Medical USA — Schaerer Medical Usa, 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
- Coulmed Products Group Llc
Sources (1)
- FDA UDI 6df41b61-3010-4c6e-af67-1cca8db1bb89 34 fields · synced Jun 8, 2026