FDA.report

ELMED

Primary DI
00842180176645
Brand
ELMED
Company
ELMED INCORPORATED
Model
33650-19
Catalog number
33650-19
Device description
OSTEOTOME, LAMBOTTE, STRAIGHT, 24CM, 19MM
Published
2023-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KDGChisel (Osteotome)

Product Code Classifications

CodeDeviceSpecialtyClass
KDGChisel (Osteotome)General, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842180176645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180176645008421801766458421801766450842180176645

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags

DUNS number
049290364
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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
00198506089763ELMED INCORPORATED52460-01-H52460-01-H2026-03-24
00198506089770ELMED INCORPORATED52460-02-H52460-02-H2026-03-24
00198506089787ELMED INCORPORATED52460-03-H52460-03-H2026-03-24
00198506089756ELMED INCORPORATED42-191042-19102026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B382SD914459320Surgical DirectSurgical Direct, Inc.KDG2026-02-25
B382SD914031000Surgical DirectSurgical Direct, Inc.KDG2026-02-20
B382SD914031010Surgical DirectSurgical Direct, Inc.KDG2026-02-20
B382SD914456290Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663010Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663020Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663030Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663040Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD914591000Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD921648100Surgical DirectSurgical Direct, Inc.KDG2026-02-09
00810158218635PRINCETONPrinceton Medical Group, Inc.KDG2026-01-20
00810158218734PRINCETONPrinceton Medical Group, Inc.KDG2026-01-20
00810158218499PRINCETONPrinceton Medical Group, Inc.KDG2026-01-15
00810158218536PRINCETONPrinceton Medical Group, Inc.KDG2026-01-15
B382SD48820520Surgical DirectSurgical Direct, Inc.KDG2025-12-02
00810158218086PRINCETONPrinceton Medical Group, Inc.KDG2025-11-24
00810158217393PRINCETONPrinceton Medical Group, Inc.KDG2025-09-29
B382SD9219563010Surgical DirectSurgical Direct, Inc.KDG2025-09-22
B382SD936682100Surgical DirectSurgical Direct, Inc.KDG2025-09-18
B382SD9146891000Surgical DirectSurgical Direct, Inc.KDG2025-09-12
00810158216471PRINCETONPrinceton Medical Group, Inc.KDG2025-08-21
00810158215894PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216044PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216051PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216068PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216075PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216082PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
B382SD921381020Surgical DirectSurgical Direct, Inc.KDG2025-08-11
B382SD921646030Surgical DirectSurgical Direct, Inc.KDG2025-08-11
B382SD921646040Surgical DirectSurgical Direct, Inc.KDG2025-08-11