Bookler Table Mounted Retractor Systems

GUDID 00842102115295

Blade, Reversed St.Mark's, Modified, 9"D, w/Lip, w/Bkwltr Hd

FLEXBAR MACHINE CORPORATION

Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable
Primary Device ID00842102115295
NIH Device Record Keyce6f92bd-46c7-4fc6-8276-a0c96038362c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBookler Table Mounted Retractor Systems
Version Model Number75742
Company DUNS047644935
Company NameFLEXBAR MACHINE CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842102115295 [Primary]

FDA Product Code

FFORetractor, Self-Retaining

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842102115295]

Moist Heat or Steam Sterilization

[00842102115295]

Moist Heat or Steam Sterilization

[00842102115295]

Moist Heat or Steam Sterilization

[00842102115295]

Moist Heat or Steam Sterilization

[00842102115295]

Moist Heat or Steam Sterilization

[00842102115295]

Moist Heat or Steam Sterilization

[00842102115295]

Moist Heat or Steam Sterilization

[00842102115295]

Moist Heat or Steam Sterilization

[00842102115295]

Moist Heat or Steam Sterilization

[00842102115295]

Moist Heat or Steam Sterilization

[00842102115295]

Moist Heat or Steam Sterilization

[00842102115295]

Moist Heat or Steam Sterilization

[00842102115295]

Moist Heat or Steam Sterilization

[00842102115295]

Moist Heat or Steam Sterilization

[00842102115295]

Moist Heat or Steam Sterilization

[00842102115295]

Moist Heat or Steam Sterilization

[00842102115295]

Moist Heat or Steam Sterilization

[00842102115295]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-13
Device Publish Date2023-04-05

On-Brand Devices [Bookler Table Mounted Retractor Systems]

00842102113079Richardson Blade with Bookler Handle, 19mm x 51mm
00842102112522S-shaped Retractors for Hasson Cannulas, ½" width, 2 ea
00842102112515S-shaped Retractors for Hasson Cannulas, 3/8" width, 2 ea
00842102112508S-shaped Retractors for Hasson Cannulas, ¼" width, 2 ea
00842102107498The EAGLE StrongArm Plus Split Ring Frame, Large, Adjustable
00842102107481Delrin Post Coupling 1" X 1"
00842102107474Quick Lock SS Post Coupling, 1 x 1" (2.5 x 2.5cm)
00842102107467Field Post, Elevator Adjustable 9 - 14" (23 - 36cm)
00842102107450Elevator Adjustable Field Post 12 - 18" (30 - 45cm)
00842102107443Instrument Holster Tube Accessory for Lap-Rack™
00842102107436Lap-Rack™ Frame (no coupler)
00842102107429Rail Clamp Converter for Over-sized Table Rails
00842102107412The EAGLE StrongArm Plus Split Ring Frame, Small, Adjustable
00842102107405Bookler Bariatric Accessory Set w/24" Post
00842102107399Bookler Bariatric Deluxe System w/24" Field Post
00842102107382Bookler Bariatric Deluxe System w18" Field Post
00842102107375Original Bariatric System 24" (60cm) Table Post
00842102107368Perineal Surgery System
00842102107351Deluxe GYN System
00842102107344Ring, Round Small, 8 1/2" (21.6cm) Diameter
00842102107337Ring, Round, Large, 12 1/2 (31.8cm) Diameter
00842102107320Ring, Round, Medium, 10 1/2 (26.7cm) Diameter
00842102107313Ring, Segmented, Small, 8 1/2 x 14" (21.6 x 35.6 cm)
00842102107306Ring, Segmented, Large, 12 1/2" x 19" (31.8 x 48.3cm)
00842102107290Horizontal Bar, 1" (2.5cm) Diameter with 2" (5.1cm) fluted knob
00842102107283Bookler-StrongArm Plus, General Surgery System
00842102107276General Surgery Basic Starter System (no Blades)
00842102107269General Surgery Basic Starter System (no Blades)
00842102107252Bookler Blade, Balfour 2 3/4" x 2"
00842102107245Bookler Blade, Balfour 2 3/4" x 2"
00842102107238Bookler Goulet Retractor 1 1/4 x 1 1/4" (3.2 x 3.2cm)
00842102107221Bookler Richardson Retractor 1 x 1 1/2" (2.5 x 3.8cm)
00842102107214Bookler Right Angle Retractor 1/2 x 1 1/2" (1.3 x 3.8cm)
00842102107207Bookler Right Angle Retractor 1/2 x 1" (1.3 x 2.5cm)
00842102107191Bookler 4-Prong Retractor with rotation
00842102107184Bookler 3-Prong Retractor with rotation
00842102107177Bookler Single Prong Urology Retractor
00842102107160Univ. Rail Clamp Extender
00842102107153The EAGLE Split Ring Frame, Small, Adjustable
00842102107146The EAGLE Split Ring Frame, Large, Adjustable
00842102107139Bookler Vertical Extension Bar Kit
00842102107122Blade, Yu-Holtgrew
00842102107115Anterior Spine Assessory Set
00842102107108Posterior Spinal Retractor System
00842102107092Rectal/Trans Anal Surgeryl System
00842102107085Rectal Accessory Set
00842102107078Adolescent Surgery System
00842102107061Bariatric Accessories Kit 18" Table Post
00842102107054Original Bariatric System 18" (45cm) Table Post
00842102107047Retractor,Hook,Scoville,Large
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.