Identity
- Trade Name
- Flexarm Plus Surgical Holders and Positioners FDA UDI
- Generic Name
- Surgical instrument assist arm system, manually-adjusted FDA UDI
- Device Name
- Univ. Single FlexArm Plus System, fixed Delrin Tip FDA UDI
- Model / Reference
- 99054-D FDA UDI
- Description
- Univ. Single FlexArm Plus System, fixed Delrin Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842102110603 FDA UDI
- FDA Product Code
- BWN FDA UDI
- GMDN Term
- Surgical instrument assist arm system, manually-adjusted 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Surgical instrument assist arm system, manually-adjusted
Flexarm Plus Surgical Holders and Positioners by Flexbar Machine Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Flexbar Machine Corp.
Sources (1)
- FDA UDI 1f5c3c03-1473-42c1-896f-de94d3fd8aa2 33 fields · synced May 30, 2026