3744N1

GUDID 00748426262083

Urology Pouch

Microtek Medical LLC

Surgical tissue/fluid collection bag
Primary Device ID00748426262083
NIH Device Record Keydc5900e6-b4f2-48fc-9e99-f7cc8771de97
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberPatient Drapes
Catalog Number3744N1
Company DUNS106908437
Company NameMicrotek Medical LLC
Device Count150
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100748426262083 [Unit of Use]
GS120748426262087 [Primary]

FDA Product Code

PUIDrape, Surgical, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-12
Device Publish Date2025-12-04

Devices Manufactured by Microtek Medical LLC

10748426141675 - Armatec®2025-12-23 DRAPE FOR LEICA OH4/OH3/OHS/MS2/MS3/F40, 117 cm x 305 cm (46 in x 120 in)
10748426145154 - Medline-Microtek2025-12-23 Patient Drape, ISODrape™ Towel Drape - Large, 46 cm x 61 cm (18 in x 24 in)
10748426145178 - Medline-Microtek2025-12-23 Microscope Drape, For Zeiss OPMI, 104 cm x 203 cm (41 in x 80 in)
10748426145185 - Medline-Microtek2025-12-23 Microscope Laser Drape, 104 cm x 305 cm (41 in x 120 in)
20748426262223 - Medline-Microtek2025-12-22 THERMABASIN, BASIN WITH ATTACHED DRAPE FOR USE WITH THE INTRATEMP SOLUTION WARMER
10748426145833 - Medline-Microtek2025-12-18 Microscope Drape, For Zeiss with Vari-Lens™, 122 cm x 305 cm (48 in x 120 in)
10748426145840 - Medline-Microtek2025-12-18 Microscope Drape, For Zeiss MD with Vari-Lens™, 122 cm x 203 cm (48 in x 80 in)
10748426145857 - Medline-Microtek2025-12-18 Microscope Drape, For Zeiss MD with Vari-Lens™, 132 cm x 381 cm (52 in x 150 in)

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