Reprocessed Werewolf Irrigation Tube Set

GUDID B390722901351

SURETEK MEDICAL

Surgical irrigation tubing set, single-use
Primary Device IDB390722901351
NIH Device Record Keyb721335a-6c48-4573-9955-19f4baa2ce3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed Werewolf Irrigation Tube Set
Version Model Number72290135
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
HIBCCB390722901351 [Primary]

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-18
Device Publish Date2024-11-08

Devices Manufactured by SURETEK MEDICAL

B3902141071 - Reprocessed Distal Rib Clear Cannula with Obturator, 5.5mm x 75mm2024-12-23
B3902141081 - Reprocessed Threaded Clear Cannula with Obturator, 5.5mm x 75mm2024-12-23
B390AR406845L1 - Reprocessed SutureLasso, 45 Deg, Curve Left2024-12-23
B390S8966561 - Reprocessed Sagittal Saw Blade, 90 x 19 x 1.27mm2024-12-23
B390AR8750131 - Reprocessed 3.7mm Cannulated Drill Bit2024-11-27
B390722901351 - Reprocessed Werewolf Irrigation Tube Set2024-11-18
B390722901351 - Reprocessed Werewolf Irrigation Tube Set2024-11-18
B390AR65301 - Reprocessed Twist-in Cannula w/Obturator, 8.25mm x 7cm2024-10-28
B39057S000221 - Reprocessed Mica Drill Bit, 2.2mm 2024-10-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.