Reprocessed ECTRA II, Probe Knife

GUDID B39044471

SURETEK MEDICAL

Hand ligament surgical release instrument
Primary Device IDB39044471
NIH Device Record Key261d79a1-4bf5-459a-ab48-39e2f534f8c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed ECTRA II, Probe Knife
Version Model Number4447
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
HIBCCB39044471 [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 Date2024-02-29
Device Publish Date2024-02-21

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