Large Staple Clamp

GUDID M209176520

BIOPRO, INC.

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Primary Device IDM209176520
NIH Device Record Key7e9c0ab8-e227-4c54-b08b-0d43f3474b7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameLarge Staple Clamp
Version Model Number17652
Company DUNS618749857
Company NameBIOPRO, INC.
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 Numberfalse
Manufacturing Datetrue
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
HIBCCM209176520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M209176520]

Moist Heat or Steam Sterilization


[M209176520]

Moist Heat or Steam Sterilization


[M209176520]

Moist Heat or Steam Sterilization


[M209176520]

Moist Heat or Steam Sterilization


[M209176520]

Moist Heat or Steam Sterilization


[M209176520]

Moist Heat or Steam Sterilization


[M209176520]

Moist Heat or Steam Sterilization


[M209176520]

Moist Heat or Steam Sterilization


[M209176520]

Moist Heat or Steam Sterilization


[M209176520]

Moist Heat or Steam Sterilization


[M209176520]

Moist Heat or Steam Sterilization


[M209176520]

Moist Heat or Steam Sterilization


[M209176520]

Moist Heat or Steam Sterilization


[M209176520]

Moist Heat or Steam Sterilization


[M209176520]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-09
Device Publish Date2019-05-01

On-Brand Devices [Large Staple Clamp]

M20917652017652
0081001248381017652

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