Bookler Table Mounted Retractor Systems

FDA UDI

Class I (US FDA UDI)

by Flexbar Machine Corp.

Identity

Trade Name: Bookler Table Mounted Retractor Systems FDA UDI
Generic Name: Surgical retraction system, reusable FDA UDI
Device Name: The EAGLE Split Ring Frame, Small, Adjustable FDA UDI
Model / Reference: 72201 FDA UDI
Description: The EAGLE Split Ring Frame, Small, Adjustable FDA UDI

Identifiers

Primary DI / UDI-DI: 00842102107153 FDA UDI
FDA Product Code: FFO FDA UDI
GMDN Term: Surgical retraction system, reusable 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical retraction system, reusable

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 retraction system, reusable.

45930R — Thompson Surgical Instruments, Inc. · Class IIa
Sigma — ALPHATEC SPINE, INC. · Class I
Omni-Tract® — Integra Lifesciences Corp. · Class I
Drills and Handpieces — SOUTHERN IMPLANTS (PTY) LTD · Class IIa
Thompson — Thompson Surgical Instruments · Class I
Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
Thompson — Thompson Surgical Instruments · Class I
Thompson — Thompson Surgical Instruments · 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: Flexbar Machine Corp.

Sources (1)

FDA UDI 774ae9ee-09b3-4e02-bb74-d41cd6994798 33 fields · synced May 30, 2026