Identity
- Trade Name
- Flexarm Plus Surgical Holders and Positioners FDA UDI
- Generic Name
- Surgical instrument assist arm system, manually-adjusted FDA UDI
- Device Name
- Bookler Endo FlexArm Plus Sys, 12" Post, Delrin Tip FDA UDI
- Model / Reference
- 99106 FDA UDI
- Description
- Bookler Endo FlexArm Plus Sys, 12" Post, Delrin Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842102112669 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
Category: Surgical instrument assist arm system, manually-adjusted
Flexarm Plus Surgical Holders and Positioners is a manually-adjusted, commercially available device designed to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure.
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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 ad6fe153-26d0-486a-944d-60ed2a7a7403 33 fields · synced Jul 20, 2026