FDA.reportPublic FDA data

Sklar

Primary DI
10649111122569
Brand
Sklar
Company
SKLAR CORPORATION
Model
75-2201
Device description
LINDEMANN BURR 65MM MED
Published
2019-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTTBURR, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTTBurr, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10649111122569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911112256910649111122569

GMDN Terms#

Term, Definition table
TermDefinition
Tongue depressor, surgicalA hand-held surgical instrument designed to displace and maintain the tongue in a fixed position, usually by depressing it towards the floor of the mouth. It is typically a metallic (e.g., high-grade stainless steel) device either with a straight shape, or more frequently smoothly bent at its center (e.g., to a 90? arch). The proximal end is used as a handle, while the distal end (usually serrated and may include holes) is used to depress the tongue. The device is used in oral surgery (e.g., during tonsillectomy). 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
07899258658230Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658247Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658254Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658261Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658278Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658285Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258638867Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
07899258638874Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
07899258638881Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
07899258638898Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
07899258638911Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
07899258638928Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
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08809288930038IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
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08809288930052IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
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08809288930083IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
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08809288930120IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930137IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
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08809288930151IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930168IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930175IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13