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Lateral Brace for shoulder positioners**
FDA UDIClass I (US FDA UDI)
by Skytron, LLC
Identity
- Trade Name
- Lateral Brace for shoulder positioners** FDA UDI
- Generic Name
- Universal operating table top FDA UDI
- Device Name
- Lateral Brace for shoulder positioners** FDA UDI
- Model / Reference
- 3-010-04 FDA UDI
- Description
- Lateral Brace for shoulder positioners** FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841736112394 FDA UDI
- FDA Product Code
- LWG FDA UDI
- GMDN Term
- Universal operating table top 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: Universal operating table top
Lateral Brace for shoulder positioners** by Skytron, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Universal operating table top.
- AUXILIARY IMAGING TOP — Mizuho Orthopedic Systems, Inc. · Class I
- Back plate — Maquet, Inc. · Class I
- Back plate — Maquet, Inc. · Class I
- SchureMed — SCHUERCH CORPORATION · Class I
- Shoulder module — Maquet, Inc. · Class I
- Carbon fibre back plate — Maquet, Inc. · Class I
- Carbon fibre back plate — Maquet, Inc. · Class I
- Pediatric Table, OPERON D 750-D 850 (US) — Qfix · 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
- Skytron, LLC
Sources (1)
- FDA UDI bc22286f-1133-4bfd-a4ba-f8fa692e213d 34 fields · synced May 30, 2026