Bookler Table Mounted Retractor Systems

GUDID 00842102107245

Bookler Blade, Balfour 2 3/4" x 2"

FLEXBAR MACHINE CORPORATION

Surgical retractor/retraction system blade, reusable

• Primary Device ID: 00842102107245
• NIH Device Record Key: e0d564a1-6bb6-4006-8196-c529e771bb0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bookler Table Mounted Retractor Systems
• Version Model Number: 75314
• Company DUNS: 047644935
• Company Name: FLEXBAR MACHINE CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842102107245 [Primary]

FDA Product Code

• FFO: Retractor, Self-Retaining

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00842102107245]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-01-09

On-Brand Devices [Bookler Table Mounted Retractor Systems]

• 00842102113079: Richardson Blade with Bookler Handle, 19mm x 51mm
• 00842102112522: S-shaped Retractors for Hasson Cannulas, ½" width, 2 ea
• 00842102112515: S-shaped Retractors for Hasson Cannulas, 3/8" width, 2 ea
• 00842102112508: S-shaped Retractors for Hasson Cannulas, ¼" width, 2 ea
• 00842102107498: The EAGLE StrongArm Plus Split Ring Frame, Large, Adjustable
• 00842102107481: Delrin Post Coupling 1" X 1"
• 00842102107474: Quick Lock SS Post Coupling, 1 x 1" (2.5 x 2.5cm)
• 00842102107467: Field Post, Elevator Adjustable 9 - 14" (23 - 36cm)
• 00842102107450: Elevator Adjustable Field Post 12 - 18" (30 - 45cm)
• 00842102107443: Instrument Holster Tube Accessory for Lap-Rack™
• 00842102107436: Lap-Rack™ Frame (no coupler)
• 00842102107429: Rail Clamp Converter for Over-sized Table Rails
• 00842102107412: The EAGLE StrongArm Plus Split Ring Frame, Small, Adjustable
• 00842102107405: Bookler Bariatric Accessory Set w/24" Post
• 00842102107399: Bookler Bariatric Deluxe System w/24" Field Post
• 00842102107382: Bookler Bariatric Deluxe System w18" Field Post
• 00842102107375: Original Bariatric System 24" (60cm) Table Post
• 00842102107368: Perineal Surgery System
• 00842102107351: Deluxe GYN System
• 00842102107344: Ring, Round Small, 8 1/2" (21.6cm) Diameter
• 00842102107337: Ring, Round, Large, 12 1/2 (31.8cm) Diameter
• 00842102107320: Ring, Round, Medium, 10 1/2 (26.7cm) Diameter
• 00842102107313: Ring, Segmented, Small, 8 1/2 x 14" (21.6 x 35.6 cm)
• 00842102107306: Ring, Segmented, Large, 12 1/2" x 19" (31.8 x 48.3cm)
• 00842102107290: Horizontal Bar, 1" (2.5cm) Diameter with 2" (5.1cm) fluted knob
• 00842102107283: Bookler-StrongArm Plus, General Surgery System
• 00842102107276: General Surgery Basic Starter System (no Blades)
• 00842102107269: General Surgery Basic Starter System (no Blades)
• 00842102107252: Bookler Blade, Balfour 2 3/4" x 2"
• 00842102107245: Bookler Blade, Balfour 2 3/4" x 2"
• 00842102107238: Bookler Goulet Retractor 1 1/4 x 1 1/4" (3.2 x 3.2cm)
• 00842102107221: Bookler Richardson Retractor 1 x 1 1/2" (2.5 x 3.8cm)
• 00842102107214: Bookler Right Angle Retractor 1/2 x 1 1/2" (1.3 x 3.8cm)
• 00842102107207: Bookler Right Angle Retractor 1/2 x 1" (1.3 x 2.5cm)
• 00842102107191: Bookler 4-Prong Retractor with rotation
• 00842102107184: Bookler 3-Prong Retractor with rotation
• 00842102107177: Bookler Single Prong Urology Retractor
• 00842102107160: Univ. Rail Clamp Extender
• 00842102107153: The EAGLE Split Ring Frame, Small, Adjustable
• 00842102107146: The EAGLE Split Ring Frame, Large, Adjustable
• 00842102107139: Bookler Vertical Extension Bar Kit
• 00842102107122: Blade, Yu-Holtgrew
• 00842102107115: Anterior Spine Assessory Set
• 00842102107108: Posterior Spinal Retractor System
• 00842102107092: Rectal/Trans Anal Surgeryl System
• 00842102107085: Rectal Accessory Set
• 00842102107078: Adolescent Surgery System
• 00842102107061: Bariatric Accessories Kit 18" Table Post
• 00842102107054: Original Bariatric System 18" (45cm) Table Post
• 00842102107047: Retractor,Hook,Scoville,Large