Nylon Extra Large Retrieval Pouch

GUDID B3548111

Nylon Extra Large Retrieval Pouch

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Primary Device IDB3548111
NIH Device Record Keyd85b2f78-e302-4663-90fc-80a2a5f79732
Commercial Distribution StatusIn Commercial Distribution
Brand NameNylon Extra Large Retrieval Pouch
Version Model NumberB354OS811RP
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
HIBCCB3548111 [Unit of Use]
HIBCCB354OS811RP1 [Primary]
HIBCCB354OS811RP2 [Primary]
HIBCCB354OS811RP3 [Primary]
HIBCCB354OS811RP4 [Primary]
HIBCCB354OS811RP5 [Primary]
HIBCCB354OS811RP9 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

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Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-17
Device Publish Date2023-07-08

On-Brand Devices [Nylon Extra Large Retrieval Pouch]

B354OS811RP0Nylon Extra Large Retrieval Pouch
B3548111Nylon Extra Large Retrieval Pouch

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