3 Ring Suture Passer - Kit OS3CDKS

GUDID B354OS3CDKS0

3 Ring Suture Passer - Kit with 5mm and 10mm swab

ORANGE SURGICAL INSTRUMENTS, LLC

Laparoscopic wound closure thread
Primary Device IDB354OS3CDKS0
NIH Device Record Keyac180d9e-6632-4f19-8400-c11b2ab0bcb4
Commercial Distribution Discontinuation2023-03-18
Commercial Distribution StatusIn Commercial Distribution
Brand Name3 Ring Suture Passer - Kit
Version Model NumberOS3CDKS
Catalog NumberOS3CDKS
Company DUNS047063695
Company NameORANGE SURGICAL INSTRUMENTS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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
HIBCCB354OS3CDKS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-19
Device Publish Date2021-01-11

On-Brand Devices [3 Ring Suture Passer - Kit]

B354OS3CDK03 Ring Suture Passer - Kit
B354OS3CDKS03 Ring Suture Passer - Kit with 5mm and 10mm swab

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.