Reprocessed QuickPass SutureLasso, 45 Deg, Curve, Left, w/out Nitinol Wire

GUDID B390AR606845LX1

SURETEK MEDICAL

Suturing unit, reprocessed
Primary Device IDB390AR606845LX1
NIH Device Record Keyeb758ff2-2a95-4eb0-9ab4-e490bc5388c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed QuickPass SutureLasso, 45 Deg, Curve, Left, w/out Nitinol Wire
Version Model NumberAR-6068-45L-X
Company DUNS785616934
Company NameSURETEK MEDICAL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB390AR606845LX1 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-16
Device Publish Date2024-09-06

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