FDA.reportPublic FDA data

ELMED

Primary DI
00842180179806
Brand
ELMED
Company
ELMED INCORPORATED
Model
23-294
Catalog number
23-294
Device description
"HOKE OSTEOTOME, 5 -1/2"" (140MM), CURVED, 9MM"
Published
2023-10-10
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
KDGChisel (Osteotome)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDGChisel (Osteotome)General, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180179806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180179806008421801798068421801798060842180179806

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
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
Device count
1
Premarket exempt
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506090967ELMED INCORPORATED37120-3537120-352026-05-26
00198506090974ELMED INCORPORATEDSTE36101ESTE36101E2026-05-26
00198506090981ELMED INCORPORATEDSTE3641ESTE3641E2026-05-26
00198506090998ELMED INCORPORATEDSTE245013STE2450132026-05-26
00198506091001ELMED INCORPORATEDSTE245014STE2450142026-05-26
00198506091018ELMED INCORPORATEDSTE245015STE2450152026-05-26
00198506091025ELMED INCORPORATEDSTE245016STE2450162026-05-26
00198506091032ELMED INCORPORATEDSTE245017STE2450172026-05-26
00198506091049ELMED INCORPORATEDSTE245018STE2450182026-05-26
00198506091056ELMED INCORPORATEDSTE245019STE2450192026-05-26
00198506091063ELMED INCORPORATEDSTE245020STE2450202026-05-26
00198506091070ELMED INCORPORATEDSTE245021STE2450212026-05-26
00198506091087ELMED INCORPORATEDSTE245022STE2450222026-05-26
00198506091100ELMED INCORPORATEDSTE322924ISTE322924I2026-05-26
00198506091117ELMED INCORPORATEDSTE322923ISTE322923I2026-05-26
00198506091124ELMED INCORPORATEDSTE3211221ESTE3211221E2026-05-26
00198506090899ELMED INCORPORATEDSM13600-10SM13600-102026-05-19
00198506090905ELMED INCORPORATED33370-2733370-272026-05-19
00198506090912ELMED INCORPORATED35-6291435-629142026-05-19
00198506090929ELMED INCORPORATED33761-2133761-212026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD921381110Surgical DirectSurgical Direct, Inc.KDG2026-02-12
B382SD9144841130Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9144841180Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9144841190Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD921613120Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9233201100Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9233201110Surgical DirectSurgical Direct, Inc.KDG2025-11-05
00198506086465ELMED INCORPORATEDELMED INCORPORATEDKDG2025-11-05
B382SD62622020Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622040Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622060Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622070Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622080Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622090Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622100Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622120Surgical DirectSurgical Direct, Inc.KDG2025-10-14
00810158217577PRINCETONPrinceton Medical Group, Inc.KDG2025-10-08
00810158216938PRINCETONPrinceton Medical Group, Inc.KDG2025-09-10
10840199528834Comfort Plus ChiselKOROS U.S.A., INC.KDG2025-01-31
10888277381339MEDLINEMEDLINE INDUSTRIES, INC.KDG2025-01-29
10888277392304MEDLINEMEDLINE INDUSTRIES, INC.KDG2025-01-29
10840199511423ChiselKOROS U.S.A., INC.KDG2024-12-31
10840199511430ChiselKOROS U.S.A., INC.KDG2024-12-31
10840199527394OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527400OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527417OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527424OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527431OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527448OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527455OsteotomeKOROS U.S.A., INC.KDG2024-12-31