FILBLOC PERMANENT

GUDID 38033439007770

ASSUT EUROPE SPA

Barbed polyolefin suture
Primary Device ID38033439007770
NIH Device Record Keyab1d8ad5-8caa-4cac-8ce1-25fef4550dec
Commercial Distribution StatusIn Commercial Distribution
Brand NameFILBLOC PERMANENT
Version Model NumberPY893K
Company DUNS654747567
Company NameASSUT EUROPE SPA
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS138033439007770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAWSuture, Nonabsorbable, Synthetic, Polypropylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-19
Device Publish Date2024-08-09

On-Brand Devices [FILBLOC PERMANENT]

18033439180042PLY-G02-020-APL
18033439178889PLY-G02-020-A
18033439169238PS028HHAC
18033439164295PU693IHBQ
38033439008968PU543
38033439007770PY893K
38033439007435PS920
38033439007190PY891
38033439007138PZ890

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