Identity
- Trade Name
- OB hand grips** (pr.) FDA UDI
- Generic Name
- Arm procedure positioner, reusable FDA UDI
- Device Name
- OB hand grips** (pr.) FDA UDI
- Model / Reference
- 2-050-01 FDA UDI
- Description
- OB hand grips** (pr.) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841736112325 FDA UDI
- FDA Product Code
- LWG FDA UDI
- GMDN Term
- Arm procedure positioner, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Arm procedure positioner, reusable
OB hand grips** (pr.) by Skytron, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arm procedure positioner, reusable.
- Coulmed — COULMED PRODUCTS GROUP LLC · Class I
- MTI — MEDICAL TECHNOLOGY INDUSTRIES, INC. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- MTI — MEDICAL TECHNOLOGY INDUSTRIES, INC. · Class I
- Coulmed — COULMED PRODUCTS GROUP LLC · Class I
- MTI — MEDICAL TECHNOLOGY INDUSTRIES, INC. · Class I
- ALLEN — HILL-ROM, INC. · Class I
- MTI — MEDICAL TECHNOLOGY INDUSTRIES, 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
- Skytron, LLC
Sources (1)
- FDA UDI 8846f3da-e709-4b9d-afab-b0bb1b6094c3 34 fields · synced May 31, 2026