Lap-port closure device guides 5mm and 10/12 mm Re OSLPCDGR

GUDID B354OSLPCDGR510120

Lap-port closure device guides 5mm and 10/12 mm Reusable

ORANGE SURGICAL INSTRUMENTS, LLC

Laparoscopic wound closure thread
Primary Device IDB354OSLPCDGR510120
NIH Device Record Key9c1d9055-b05a-4a39-aa5b-8eaf632c6f2c
Commercial Distribution Discontinuation2021-03-28
Commercial Distribution StatusIn Commercial Distribution
Brand NameLap-port closure device guides 5mm and 10/12 mm Re
Version Model NumberOSLPCDGR
Catalog NumberOSLPCDGR
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB354OSLPCDGR510120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


[B354OSLPCDGR510120]

Peracetic Acid


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-04-30
Device Publish Date2018-03-28

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