FDA.reportPublic FDA data

Sklar

Primary DI
10649111342424
Brand
Sklar
Company
SKLAR CORPORATION
Model
40-8344
Device description
HOEN ELEV 20MM 7.25 INCHES
Published
2019-04-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10649111342424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911134242410649111342424

GMDN Terms#

Term, Definition table
TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery (e.g., dental, orthopaedic), including use on the ribs. In dentistry it may be used to access retained roots, or for their removal with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
10649111184420Sklar40-73182019-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995267995Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268008Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268015Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268022Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268039Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268046Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00190776431600MillenniumAvalign Technologies, Inc.GEG2026-09-22
00190776424091MillenniumAvalign Technologies, Inc.GEG2026-08-27
00190776428297MillenniumAvalign Technologies, Inc.GEG2026-08-27
00190776427733MillenniumAvalign Technologies, Inc.GEG2026-08-26
00190776427245MillenniumAvalign Technologies, Inc.GEG2026-08-21
00190776422646MillenniumAvalign Technologies, Inc.GEG2026-08-03
00190776422851MillenniumAvalign Technologies, Inc.GEG2026-08-03
B382SD350110Surgical DirectSurgical Direct, Inc.GEG2026-08-03
B382SD38060Surgical DirectSurgical Direct, Inc.GEG2026-08-03
B382SD4833125SN0Surgical DirectSurgical Direct, Inc.GEG2026-08-03
00190776422448MillenniumAvalign Technologies, Inc.GEG2026-07-31
00810143904598SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904604SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904611SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904628SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904642SURGIPROSSurgipros, LLCGEG2026-07-30
00810143906264SURGIPROSSurgipros, LLCGEG2026-07-30
00810143906325SURGIPROSSurgipros, LLCGEG2026-07-30
00810143906370SURGIPROSSurgipros, LLCGEG2026-07-30
00810143907254SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934068SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934075SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934082SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934099SURGIPROSSurgipros, LLCGEG2026-07-30