BioWick SureLock

GUDID 00887868269769

BioWick SureLock 2.7mm Pre-Loaded Implant

CAYENNE MEDICAL, INC.

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable
Primary Device ID00887868269769
NIH Device Record Key54abd454-d731-4fe4-b783-621d31a30439
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioWick SureLock
Version Model NumberCM-6127
Company DUNS606719685
Company NameCAYENNE MEDICAL, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100887868269769 [Primary]
HIBCCM543CM6127 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-29
Device Publish Date2020-09-21

On-Brand Devices [BioWick SureLock]

00887868269769BioWick SureLock 2.7mm Pre-Loaded Implant
M543CM6127BioWick SureLock 2.7mm Pre-Loaded Implant

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