FDA.reportPublic FDA data

Recon

Primary DI
G318102991040
Brand
Recon
Company
Revelation Medical Devices
Model
10-2991-04
Catalog number
10-2990-04
Device description
Wide WEJ Retractor short tip
Published
2025-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G318102991040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
260-925-1382office@rmdusa.com

Regulatory Flags#

DUNS number
122296421
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G318108831520Recon10-883-15-310-883-15-22026-03-30
G3181029930Recon10-299310-29932025-06-11
G3181029920Recon10-299210-29922025-04-04
G318102991060Recon10-2991-0610-2990-062025-03-10
G318107832509Recon10-783-2510-783-252025-01-21
G318107720000Recon10-772-0010-772-002024-12-09
G3181088315009Recon10-883-15-010-883-15-02024-12-09
G318108831510Recon10-883-15-110-883-15-12024-12-09
G3181014841002Recon10-1484-1010-1484-102024-09-17
G3181029910106Recon10-2991-0110-2990-012024-08-27
G3181029910308Recon10-2991-0310-2990-032024-08-27
G318108831530Recon10-883-15-310-883-15-32024-08-01
G31810299004Recon10-299010-29902024-07-05
G31810772470Recon10-772-4710-772-472024-06-19
G318107725308Recon10-772-5310-772-532024-06-19
G31810772580Recon10-772-5810-772-582024-06-19
G31810772630Recon10-772-6310-772-632024-06-19
G318108831540Recon10-883-15-410-883-15-42024-06-10
G3181029880Recon10-298810-29882024-05-24
G3181029890Recon10-298910-29892024-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049047155324GimmiGimmi GmbHGAD2026-06-08
G453PM1580030BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-06-08
00846159040524SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040531SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040548SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040555SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040562SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040579SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040586SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040593SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040609SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040616SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040623SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00841536147230ThompsonThompson Surgical Instruments, Inc.GAD2026-06-03
00846159040388SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040395SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040401SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040418SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040425SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040432SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040449SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040456SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040463SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040470SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040487SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040494SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040500SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040517SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040272SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040289SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02