Reusable Ratchet Handle - Tips 34cm OS-3-R

GUDID B354OS3R10

Reusable Ratchet Handle - Tips 34cm

ORANGE SURGICAL INSTRUMENTS, LLC

Tissue extraction bag
Primary Device IDB354OS3R10
NIH Device Record Key9fd50758-fba9-4a33-9bce-45dd79256c42
Commercial Distribution Discontinuation2019-11-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameReusable Ratchet Handle - Tips 34cm
Version Model NumberOS-3-R
Catalog NumberOS-3-R
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 Batchfalse
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
HIBCCB354OS3R0 [Primary]
HIBCCB354OS3R10 [Package]
Contains: B354OS3R0
Package: [10 Units]
Discontinued: 2019-11-14
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


[B354OS3R10]

Peracetic Acid


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-14
Device Publish Date2016-11-14

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