Primary Device ID | B354336 |
NIH Device Record Key | 374640d6-2b71-4c7e-acc9-a9463378f700 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bowel Grasper Inner Shaft |
Version Model Number | C336 |
Company DUNS | 047063695 |
Company Name | ORANGE SURGICAL INSTRUMENTS, LLC |
Device Count | 99999 |
DM Exempt | false |
Pre-market Exempt | false |
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 | true |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B354336 [Unit of Use] |
HIBCC | B354C3361 [Primary] |
HIBCC | B354C3362 [Primary] |
HIBCC | B354C3363 [Primary] |
HIBCC | B354C3364 [Primary] |
HIBCC | B354C3365 [Primary] |
HIBCC | B354C3369 [Primary] |
GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B354336]
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Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-24 |
Device Publish Date | 2023-07-14 |
B3543360 | Bowel Grasper Inner Shaft |
B354C3360 | Bowel Grasper Inner Shaft |
B354336 | Bowel Grasper Inner Shaft |