Primary Device ID | 00842102112959 |
NIH Device Record Key | d79a174b-f728-401e-974d-fab81fa0a8a1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Mini-Bookler Table Mounted Retractor Systems |
Version Model Number | 75641 |
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 | 00842102112959 [Primary] |
FFO | Retractor, Self-Retaining |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00842102112959]
Moist Heat or Steam Sterilization
[00842102112959]
Moist Heat or Steam Sterilization
[00842102112959]
Moist Heat or Steam Sterilization
[00842102112959]
Moist Heat or Steam Sterilization
[00842102112959]
Moist Heat or Steam Sterilization
[00842102112959]
Moist Heat or Steam Sterilization
[00842102112959]
Moist Heat or Steam Sterilization
[00842102112959]
Moist Heat or Steam Sterilization
[00842102112959]
Moist Heat or Steam Sterilization
[00842102112959]
Moist Heat or Steam Sterilization
[00842102112959]
Moist Heat or Steam Sterilization
[00842102112959]
Moist Heat or Steam Sterilization
[00842102112959]
Moist Heat or Steam Sterilization
[00842102112959]
Moist Heat or Steam Sterilization
[00842102112959]
Moist Heat or Steam Sterilization
[00842102112959]
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 |
00842102112966 | Mini-Bookler Blade, Malleable, 1 x 5" (2.5 x 12.7cm) |
00842102112959 | Mini-Bookler Blade, Malleable, Protected Edge 3/4 x 4" (1.9 x 10.2cm) |
00842102112942 | Mini-Bookler Blade, Malleable, Protected Edge 1/2 x 4" (1.3 x 10.2cm) |
00842102112935 | Mini-Bookler Blade, Deaver, 1 x 5" (2.5 x 12.7cm) |
00842102112928 | Mini-Bookler Blade, Deaver, 1 x 3 1/2" (2.5 x 8.9cm) |
00842102112911 | Mini Bookler Blade, Vaginal, Posterior, 1 x 4 1/2" (2.5 x 11.5cm) |
00842102112904 | Mini Bookler Blade, Vaginal, Lateral, 1 x 3" (2.5 x 7.6cm) |
00842102112898 | Mini Bookler Blade, Renal, Wiley, 1 x 7" (2.5x 17.8cm) |
00842102112881 | Mini Bookler Blade, Rectal, 7/8 x 3 7/8" (2.2 x 9.8cm) |
00842102112874 | Mini Bookler Blade, Rectal, 7/8 x 2 7/8" (2.2 x 7.3cm) |
00842102112539 | Clip Applier for Medium Large Clip, 10mm x 33cm |
00842102110566 | Mini-Bookler, Blade, Kelly, 1 1/2 x 4" |
00842102110559 | Mini-Bookler, Blade, Kelly, 1 1/2" x 3" - |
00842102110542 | Mini-Bookler, Blade, Kelly, 1" x 4" |
00842102110535 | Mini-Bookler Inguinal/Hernia Set |
00842102110528 | StrongArm Single w/2 Short Arms, Hudson Fitting (no Rail Clamp) |
00842102110511 | StrongArm Single w/2 Short Arms, Hudson Fitting and Rail Clamp |
00842102110504 | Mini-Bookler Clasper Attachment with Hudson Post |
00842102110498 | Mini-Bookler, Blade, Hook, Quad, Sharp |
00842102110481 | Mini-Bookler, Blade, Hook, Double, Sharp |
00842102110474 | Mini-Bookler, Blade, Hook, Single, Sharp |
00842102110467 | Mini-Bookler, Senn-Miller Triple Hook, Sharp |
00842102110450 | Mini-Bookler Hand Surgery System,Sharp Hooks |
00842102110443 | Mini-Bookler Hand Surgery System, Blunt Hook |
00842102110436 | Dardik Carotid Endarterectomy System |
00842102110429 | Mini-Bookler Ratchet Bar Attachment with Hex Fitting |
00842102110412 | Mini-Bookler Ring, Oval, Solid, 6.5 x 10" (16.5 x 25.4cm) |
00842102110405 | Mini-Bookler Adjustable Split Ring 7” (17.8cm) Closed Diameter |
00842102110399 | Mini-Bookler Tilt Ratchet |
00842102110382 | Replacement Screw (for all Mini-Bookler Ring Segments) |
00842102110375 | Mini-Bookler Twist Ratchet |
00842102110368 | Mini-Bookler, Ring, Segmented Oval 6 1/2 x 8 1/2" (16.5cm x 21.6cm) |
00842102110351 | Mini-Bookler, Ring Segments, Straight 3 1/2" (8.9cm) |
00842102110344 | Mini-Bookler, Ring, Segmented Oval 5 x 8 1/2" (12.7 x 21.6cm) |
00842102110337 | Mini-Bookler, Ring Segments, Straight 2 1/2" (6.4cm) |
00842102110320 | Mini-Bookler, Ring, Segmented Oval 6 1/2 x 10" (16.5cm x 25.4cm) |
00842102110313 | Mini-Bookler, Ring Segments, Round 61/2" (16.5cm) Diameter |
00842102110306 | Mini-Bookler, Ring, Segmented Oval 5 x 7.1/2" (12.7 x 19.1cm) |
00842102110290 | Mini-Bookler, Ring Segments, Round 5" (12.7cm) Diameter |
00842102110283 | Mini-Bookler Ring, Round, Solid, 8 1/2" (21.6cm) Diameter |
00842102110276 | Mini-Bookler Clasper Attachment |
00842102110269 | Mini-Bookler, Blade, Kelly, 3/4 x 3" (1.9 x 7.6cm) |
00842102110252 | Mini-Bookler, Blade, Kelly, 3/4 x 2 1/2" (1.9 x 6.4cm) |
00842102110245 | Mini-Bookler, Blade, Malleable 3/4 x 5" (1.9 x 12.7cm) |
00842102110238 | Mini-Bookler, Blade, Deaver, 1/2 x 2" (1.3 x 5.1cm) |
00842102110221 | Mini-Bookler, Blade, Malleable 1 1/2 x 4" (3.8 x 10.2cm) |
00842102110214 | Mini-Bookler, Blade, Malleable 1 x 4" (2.5 x 10.2cm) |
00842102110207 | Mini-Bookler, Blade, Malleable 1/2 x 4" (1.3 x 10.2cm) |
00842102110191 | Mini-Bookler, Blade, Malleable 3/4 x 4" (1.9 x 10.2cm) |
00842102110184 | Mini-Bookler, Blade, Kelly, 1 1/2 x 2" (3.8 x 5.1cm) |