REVEEL - Endoscopic Retractor - Trocar

GUDID 00811099014423

MICROLINE SURGICAL, INC.

Hand-held endoscopic retractor, single-use
Primary Device ID00811099014423
NIH Device Record Key6356e2b4-d7e4-4a91-a4ef-004a05d33462
Commercial Distribution StatusIn Commercial Distribution
Brand NameREVEEL - Endoscopic Retractor - Trocar
Version Model NumberRT083001
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
GS100811099014409 [Unit of Use]
GS100811099014416 [Primary]
GS100811099014423 [Package]
Contains: 00811099014416
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
00811099014423 - REVEEL - Endoscopic Retractor - Trocar2025-09-30
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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