HAVEL'S B68E

GUDID B070B68E1

Havel's Incorporated

Silk suture, sterile
Primary Device IDB070B68E1
NIH Device Record Keyadeeac5a-1cca-49d1-9651-c17c8c83964c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAVEL'S
Version Model NumberC7 3/0 BBS 18"/45 CM ON CARD
Catalog NumberB68E
Company DUNS101497568
Company NameHavel's Incorporated
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB070B68E0 [Primary]
HIBCCB070B68E1 [Package]
Contains: B070B68E0
Package: [12 Units]
In Commercial Distribution

FDA Product Code

GAPSuture, Nonabsorbable, Silk

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-06-16