FDA.reportPublic FDA data

Recon

Primary DI
G318101370050
Brand
Recon
Company
Revelation Medical Devices
Model
10-1370-05
Catalog number
10-1370-05
Device description
Osteotome With Phenolic Handle
Published
2022-11-28
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
G318101370050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2609251382office@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
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20888277688978MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
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