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

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10748426145123 - Muranaka2026-02-12 Microscope Drape for Zeiss MD featuring CLEARLENS™, 117 cm x 305 cm
10748426145147 - Muranaka2026-02-12 Microscope Drape for Zeiss MD featuring CLEARLENS™, 137 cm x 381 cm
10748426264008 - Muranaka2026-02-12 Microscope Drape for Zeiss MD featuring CLEARLENS™, 117 cm x 267 cm
10748426264022 - Muranaka2026-02-12 Microscope Drape for Leica featuring CLEARLENS™, 137 cm x 267 cm

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