FDA.reportPublic FDA data

ELMED

Primary DI
00842180196582
Brand
ELMED
Company
ELMED INCORPORATED
Model
ST233063
Catalog number
ST233063
Device description
"Stiletto Osteotome 8 1/2"" Straight 1/2"" [13mm]"
Published
2024-04-17
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
EMLChisel, Bone, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMLChisel, Bone, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180196582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180196582008421801965828421801965820842180196582

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
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506091667ELMED INCORPORATED32-509-04-I32-509-04-I2026-07-10
00198506091759ELMED INCORPORATED31430-00B31430-00B2026-07-10
00198506091803ELMED INCORPORATEDSTE3220413IVSTE3220413IV2026-07-10
00198506091810ELMED INCORPORATED31960-3131960-312026-07-10
00198506091827ELMED INCORPORATEDSTE321211AISTE321211AI2026-07-10
00198506091834ELMED INCORPORATEDSTE321212AISTE321212AI2026-07-10
00198506091841ELMED INCORPORATED31960-3631960-362026-07-10
00198506091858ELMED INCORPORATED31960-6331960-632026-07-10
00198506091865ELMED INCORPORATED20-2771820-277182026-07-10
00198506091872ELMED INCORPORATED9839FS9839FS2026-07-10
00198506091889ELMED INCORPORATED31560-2131560-212026-07-10
00198506091612ELMED INCORPORATED24129-10B-KW24129-10B-KW2026-06-24
00198506091629ELMED INCORPORATED24129-08B-KW24129-08B-KW2026-06-24
00198506091506ELMED INCORPORATED53020-7853020-782026-06-10
00198506091513ELMED INCORPORATEDSTE3212113ISTE3212113I2026-06-10
00198506091520ELMED INCORPORATEDSTE3212313ISTE3212313I2026-06-10
00198506091537ELMED INCORPORATED32007-1532007-152026-06-10
00198506091544ELMED INCORPORATED32006-1532006-152026-06-10
00198506091551ELMED INCORPORATED23-2503LH23-2503LH2026-06-10
00198506091575ELMED INCORPORATED23-6020-1323-6020-132026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783012316Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEML2026-04-02
00840018672505Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018672666Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018672970Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018674189Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018667396Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-10
00840018665682Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-09
00840018666030Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-09
00840018663732Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-04
00840018665491Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-04
00840018665507Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-04
00840018661202Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661219Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661226Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661233Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661240Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00194613013448MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-08-01
00194613013479MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-08-01
00194613013486MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-08-01
D92820001580BAUER GUARDED OSTEO 8MM STRW.H. Holden, Inc.EML2025-05-21
00194613013462MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-03-21
00194613104290MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-03-21
00194613108601MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-03-21
00888912126991DJO SURGICALEncore Medical, L.P.EML2024-08-22
00888912127028DJO SURGICALEncore Medical, L.P.EML2024-08-22
00887482050606Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.EML2024-08-12
00813677023254PDT, Inc.PDT, INC.EML2024-07-01
00813677023261PDT, Inc.PDT, INC.EML2024-07-01
00888912088725DJO SURGICALDJO, LLCEML2024-05-20
00842517105652Karl SchumacherKarl Schumacher Dental, LLCEML2024-05-06