ForceBraide

GUDID B048VAL2020BBT1

VALERIS MEDICAL LLC

Polyolefin suture, multifilament
Primary Device IDB048VAL2020BBT1
NIH Device Record Key82e2b7a7-afad-45a9-9fc9-092511952af5
Commercial Distribution StatusIn Commercial Distribution
Brand NameForceBraide
Version Model Number01
Company DUNS079444554
Company NameVALERIS MEDICAL 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB048VAL2020BBT0 [Primary]
HIBCCB048VAL2020BBT1 [Package]
Contains: B048VAL2020BBT0
Package: Box [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GATSuture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2017-01-25

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