Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing

GUDID B3901912050T1

SURETEK MEDICAL

Paranasal sinus irrigation catheter
Primary Device IDB3901912050T1
NIH Device Record Key741819e4-f1c9-42e5-abaa-84d9e7dbefba
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing
Version Model Number19-12050T
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
HIBCCB3901912050T1 [Primary]

FDA Product Code

KAMCannula, Sinus

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-04
Device Publish Date2023-12-27

On-Brand Devices [Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing]

B390191200T1191200T
B3901912000T119-12000T
B3901912050T119-12050T

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