| Primary Device ID | 00842102116148 |
| NIH Device Record Key | 6d20bfc7-7920-4a28-ad4c-1e767de814a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bookler Table Mounted Retractor Systems |
| Version Model Number | 75822 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00842102116148 [Primary] |
| FFO | Retractor, Self-Retaining |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00842102116148]
Moist Heat or Steam Sterilization
[00842102116148]
Moist Heat or Steam Sterilization
[00842102116148]
Moist Heat or Steam Sterilization
[00842102116148]
Moist Heat or Steam Sterilization
[00842102116148]
Moist Heat or Steam Sterilization
[00842102116148]
Moist Heat or Steam Sterilization
[00842102116148]
Moist Heat or Steam Sterilization
[00842102116148]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-27 |
| Device Publish Date | 2024-12-19 |
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| 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 |