Primary Device ID | 00842102112515 |
NIH Device Record Key | 9b832592-33e6-4495-9727-c65e366d9a76 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bookler Table Mounted Retractor Systems |
Version Model Number | 69081 |
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 | 00842102112515 [Primary] |
FFO | Retractor, Self-Retaining |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-03-11 |
Device Publish Date | 2019-01-31 |
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00842102107450 | Elevator Adjustable Field Post 12 - 18" (30 - 45cm) |
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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 |
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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 |
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