Reprocessed Large Bone Knee Blade,19.0 x 105 x 1.27mm

GUDID B39050711291

SURETEK MEDICAL

Surgical power tool system handpiece, sawing, line-powered
Primary Device IDB39050711291
NIH Device Record Key7351c6e2-3c74-4063-ac1a-2ac316c87d3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed Large Bone Knee Blade,19.0 x 105 x 1.27mm
Version Model Number5071-129
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
HIBCCB39050711291 [Primary]

FDA Product Code

GFABlade, Saw, General & Plastic Surgery, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-03
Device Publish Date2021-04-23

Devices Manufactured by SURETEK MEDICAL

B390AR606845LX1 - Reprocessed QuickPass SutureLasso, 45 Deg, Curve, Left, w/out Nitinol Wire2024-09-16
B390AR606845RX1 - Reprocessed QuickPass SutureLasso, 45 Deg, Curve, Right, w/out Nitinol Wire2024-09-16
B390KM35241 - Reprocessed Oscillating Sagittal Saw Blade, Thin, 25 x 5.5 x 0.38mm2024-09-16
B39060143261 - Reprocessed 1.4mm Twist Drill, WL 27mm, AO-Shaft2024-07-31
B3903855450001 - Reprocessed 4.0mm Formula XL Tomcat Hip Cutter2024-07-08
B390AR10001 - Reprocessed Suture Passer, Transosseous2024-05-27
B390C9944A1 - Reprocessed 2.9mm Full Radius Resector2024-05-20
B39044471 - Reprocessed ECTRA II, Probe Knife2024-02-29
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.