FDA.reportPublic FDA data

Recon

Primary DI
G318101132350
Brand
Recon
Company
Revelation Medical Devices
Model
10-1132-35
Catalog number
10-1132-35
Device description
Curved Osteotome
Published
2023-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
G318101132350PrimaryHIBCC0

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

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
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
G3181029880Recon10-298810-29882024-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800042700102Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700140Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700256Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700270Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700287Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700300Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700317Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700324Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700386Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700393Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700416Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700423Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700843Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700850Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700874Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700881Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700997Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701017Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701031Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701048Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701062Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701086Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701093Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701109Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701116ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701123ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701130ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701147ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701154ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701161ArtiSential Precise DissectorLIVSMEDMDM2026-04-29