FDA.reportPublic FDA data

Sklar

Primary DI
10649111184420
Brand
Sklar
Company
SKLAR CORPORATION
Model
40-7318
Device description
BONE CHIP PACKER 6MM, RND 10 IN
Published
2019-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10649111184420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911118442010649111184420

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
006966006
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10649111347993Sklar10-15482019-05-01
10649111501326Sklar Instruments31-40742026-03-12
10649111294235Sklar®67-10202016-10-07
10649111183386Sklar40-73122019-09-24
10649111183560Sklar40-73132019-09-24
10649111183713Sklar40-73142019-09-24
10649111183881Sklar40-73152019-09-24
10649111183997Sklar40-73162019-09-24
10649111184260Sklar40-73172019-09-24
10649111187896Sklar40-73402019-09-24
10649111087431Sklar Instruments96-01922025-11-12
10649111225369Sklar Instruments96-10922025-11-12
10649111226281Sklar Instruments96-10972025-11-12
10649111226458Sklar Instruments96-10982025-11-12
10649111226762Sklar Instruments96-11002025-11-12
10649111226984Sklar Instruments96-11022025-11-12
10649111227370Sklar Instruments96-11052025-11-12
10649111228056Sklar Instruments96-11102025-11-12
10649111228919Sklar Instruments96-11152025-11-12
10649111229817Sklar Instruments96-11202025-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867574489Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574496Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574502Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574519Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574526Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574533Arthrex®ARTHREX, INC.MDM2026-09-18
10888277688896MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688902MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688919MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688926MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688933MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688940MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688957MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688964MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277689121MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10080196321384MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277688995MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689008MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689015MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689022MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689039MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689046MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689053MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689060MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689077MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689084MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689091MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689107MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689114MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10080196320417MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-09