Bowel Grasper Inner Shaft

GUDID B354336

Bowel Grasper Inner Shaft

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical electrode, monopolar, single-use
Primary Device IDB354336
NIH Device Record Key374640d6-2b71-4c7e-acc9-a9463378f700
Commercial Distribution StatusIn Commercial Distribution
Brand NameBowel Grasper Inner Shaft
Version Model NumberC336
Company DUNS047063695
Company NameORANGE SURGICAL INSTRUMENTS, LLC
Device Count99999
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB354336 [Unit of Use]
HIBCCB354C3361 [Primary]
HIBCCB354C3362 [Primary]
HIBCCB354C3363 [Primary]
HIBCCB354C3364 [Primary]
HIBCCB354C3365 [Primary]
HIBCCB354C3369 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B354336]

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Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-24
Device Publish Date2023-07-14

On-Brand Devices [Bowel Grasper Inner Shaft]

B3543360Bowel Grasper Inner Shaft
B354C3360Bowel Grasper Inner Shaft
B354336Bowel Grasper Inner Shaft

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