REVEEL - Endoscopic Retractor - Percutaneous

GUDID 00811099014393

MICROLINE SURGICAL, INC.

Hand-held endoscopic retractor, single-use
Primary Device ID00811099014393
NIH Device Record Keycdc64292-7dca-4cfe-9313-9778be161d45
Commercial Distribution StatusIn Commercial Distribution
Brand NameREVEEL - Endoscopic Retractor - Percutaneous
Version Model NumberRV093001
Company DUNS184080570
Company NameMICROLINE SURGICAL, INC.
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
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
GS100811099014379 [Unit of Use]
GS100811099014386 [Primary]
GS100811099014393 [Package]
Contains: 00811099014386
Package: [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-30
Device Publish Date2025-09-22

Devices Manufactured by MICROLINE SURGICAL, INC.

00811099014393 - REVEEL - Endoscopic Retractor - Percutaneous2025-09-30
00811099014393 - REVEEL - Endoscopic Retractor - Percutaneous2025-09-30
00811099014423 - REVEEL - Endoscopic Retractor - Trocar2025-09-30
00811099014331 - ReNew Disposable Tenaculum Tip (5mm)2025-09-17
00811099014355 - ReNew Disposable Tenaculum Tip (10mm)2025-09-17
00811099014294 - ReNew XR Handpiece with Reference Length Markings2024-07-12
00081109901429 - ReNew XR Handpiece with Reference Length Markings2024-05-13
00811099014256 - ReNew XR Handpiece with Reference Length Markings2024-05-13
00811099014263 - ReNew XR Handpiece with Reference Length Markings2024-05-13

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