FDA.reportPublic FDA data

REVEEL - Endoscopic Retractor - Trocar

Primary DI
00811099014416
Brand
REVEEL - Endoscopic Retractor - Trocar
Company
MICROLINE SURGICAL, INC.
Model
RT083001
Published
2025-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133345000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133345000REVEEL ENDOSCOPIC RETRACTORRetraction Limited2014-04-11GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811099014423PackageGS16In Commercial Distribution
00811099014416PrimaryGS10
00811099014409Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811099014423008110990144238110990144230811099014423
00811099014416008110990144168110990144160811099014416
00811099014409008110990144098110990144090811099014409

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held endoscopic retractor, single-useA hand-held manual surgical instrument intended to be used to enable retraction of tissues during endoscopic/laparoscopic surgery. It consists of a handle with a slender body connected at the distal end to a retracting mechanism (e.g., inflatable/folding paddle, fan-like spreading mechanism, retracting hook). It is intended to be introduced through a laparoscopic port or endoscopic channel; it is not intended for wound retraction or for tissue cutting. This is a single-use device.

Regulatory Flags#

DUNS number
184080570
Device count
6
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811099014386REVEEL - Endoscopic Retractor - PercutaneousRV0930012025-09-22
00811099014393REVEEL - Endoscopic Retractor - PercutaneousRV0930012025-09-22
00811099014423REVEEL - Endoscopic Retractor - TrocarRT0830012025-09-22
00811099014348ReNew Disposable Tenaculum Tip (5mm)33922025-09-09
00811099014362ReNew Disposable Tenaculum Tip (10mm)34222025-09-09
00811099014331ReNew Disposable Tenaculum Tip (5mm)33922025-09-09
00811099014355ReNew Disposable Tenaculum Tip (10mm)34222025-09-09
00811099014294ReNew XR Handpiece with Reference Length Markings3944M2024-05-03
00081109901429ReNew XR Handpiece with Reference Length Markings3944M2024-05-03
00811099014256ReNew XR Handpiece with Reference Length Markings3943M2024-05-03
00811099014263ReNew XR Handpiece with Reference Length Markings3941M2024-05-03
00811099014270ReNew XR Handpiece with Reference Length Markings3942M2024-05-03
00811099014287ReNew XR Handpiece with Reference Length Markings3946M2024-05-03
00811099014300ReNew XR Handpiece with Reference Length Markings3945M2024-05-03
00811099013822ReNew XR353035302023-06-07
00811099013839ReNew XR353135312023-06-07
00811099013846ReNew XR35322023-06-07
00811099013853ReNew XR35332023-06-07
00811099011408Microline102-137D102-137D2017-11-13
00811099011415Microline102-138D102-138D2017-11-13

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Primary DI, Brand, Company table
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B382SD883110450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
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00190776421731MillenniumAvalign Technologies, Inc.GCJ2026-06-24
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00198506091506ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-10
00198506044366ELMEDELMED INCORPORATEDGCJ2026-06-09
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08