Reprocessed Carpal Tunnel Release Blade

GUDID B390810101

SURETEK MEDICAL

Hand ligament surgical release instrument
Primary Device IDB390810101
NIH Device Record Keyee3c5e3d-d409-4079-8740-d9417caef8c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed Carpal Tunnel Release Blade
Version Model Number81010
Company DUNS785616934
Company NameSURETEK MEDICAL
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB390810101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2024-02-02
Device Publish Date2024-01-25

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