FDA.reportPublic FDA data

Recon

Primary DI
G31810500002
Brand
Recon
Company
Revelation Medical Devices
Model
10-5000-02
Catalog number
10-5000-02
Device description
Sizer Disk Handle, 12.5°/17.5°
Published
2024-04-23
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
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G31810500002PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
G318108260ReconA10-8262022-10-25
G318108831520Recon10-883-15-310-883-15-22026-03-30
G318102991040Recon10-2991-0410-2990-042025-06-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277688988MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689190MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689206MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689213MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689220MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689237MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689244MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
20888277688978MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10080196320899MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321407MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321414MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321438MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321452MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321469MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321476MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321483MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321490MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10888277689183MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321445MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-24
00190776431587MillenniumAvalign Technologies, Inc.MDM2026-09-22
00850088713886PRINCETONPrinceton Medical Group, Inc.MDM2026-09-22
00850088713893PRINCETONPrinceton Medical Group, Inc.MDM2026-09-22
00888867574489Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574496Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574502Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574519Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574526Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574533Arthrex®ARTHREX, INC.MDM2026-09-18
10888277688896MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688902MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18