FDA.reportPublic FDA data

Adler Instrument Company

Primary DI
00810123208296
Brand
Adler Instrument Company
Company
Adler, Inc.
Model
AD05-1212
Device description
"Rubin Osteotome, w/ finger grip, TW 15mm(5/8""), cutting edge 12mm OL 165mm (6 1/2"")"
Published
2025-01-10
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
HWMOsteotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810123208296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123208296008101232082968101232082960810123208296

GMDN Terms#

Term, Definition table
TermDefinition
Plastic surgery osteotomeA surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting 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 either side with sloping curves. This device will be made of high-grade stainless steel and be used for plastic surgery procedures (e.g., to shape nasal cartilage). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8772416747orders@theadlerinstruments.com

Regulatory Flags#

DUNS number
830141235
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810220800294Adler Instrument Company38-51402026-06-02
00810220800300Adler Instrument Company50-02602026-06-02
00810220800317Adler Instrument CompanyAD760159232026-06-02
00810220800324Adler Instrument CompanyAD106-1412026-06-02
00810220800331Adler Instrument CompanyAD20-21412026-06-02
00810220800348Adler Instrument Company320-4312026-06-02
00810220800355Adler Instrument Company20-32202026-06-02
00810220800362Adler Instrument Company19-92622026-06-02
00810220800089Adler Instrument Company38-4985CC2026-05-26
00810220800102Adler Instrument CompanyAD4740002026-05-26
00810220800157Adler Instrument Company27-01002026-05-26
00810220800164Adler Instrument Company200-2822026-05-26
00810220800171Adler Instrument CompanyAD22-11552026-05-26
00810220800188Adler Instrument Company22-11002026-05-26
00810220800195Adler Instrument Company54-22322026-05-26
00810220800201Adler Instrument Company46-00902026-05-26
00810220800218Adler Instrument Company46-00932026-05-26
00810220800225Adler Instrument Company22-51802026-05-26
00810220800232Adler Instrument Company20-22112026-05-26
00810220800249Adler Instrument Company24-61372026-05-26

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