Identity
- Trade Name
- Bookler Table Mounted Retractor Systems FDA UDI
- Generic Name
- Surgical instrument assist arm system, manually-adjusted FDA UDI
- Device Name
- Holder, Retractor, Flexible, (Positractor), 5 7/8" (15cm) FDA UDI
- Model / Reference
- 69072 FDA UDI
- Description
- Holder, Retractor, Flexible, (Positractor), 5 7/8" (15cm) FDA UDI
Identifiers
- Catalog Number
- 69072 FDA UDI
- Primary DI / UDI-DI
- 00842102106071 FDA UDI
- FDA Product Code
- FFO FDA UDI
- GMDN Term
- Surgical instrument assist arm system, manually-adjusted FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument assist arm system, manually-adjusted
Bookler Table Mounted Retractor Systems by Flexbar Machine Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument assist arm system, manually-adjusted.
- II Ring Retractor — AUTOMATED MEDICAL PRODUCTS CORP. · Class I
- Scope cable holder — Olympus Medical Systems Corporation · Class II
- Smeed Technologies — SMEED TECHNOLOGIES LLC · Class I
- II Ring Retractor — AUTOMATED MEDICAL PRODUCTS CORP. · Class I
- ASSISTO® Arm-System — Geomed Medizin-Technik GmbH & Co. KG · Class II
- Holding rod — Spiggle & Theis Medizintechnik GmbH · Class I
- Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm L — KDL MEDICAL, INC. · Class I
- II Ring Retractor — AUTOMATED MEDICAL PRODUCTS CORP. · 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
- Flexbar Machine Corp.
Sources (1)
- FDA UDI 629dc67a-0902-4a80-a8b7-d308ecbd6d70 34 fields · synced May 30, 2026