FDA.reportPublic FDA data

Sklar

Primary DI
10649111454974
Brand
Sklar
Company
SKLAR CORPORATION
Model
84901
Device description
HUDSON BURR 16MM
Published
2019-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
10649111454974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911145497410649111454974

GMDN Terms#

Term, Definition table
TermDefinition
Drilling power tool attachment, basicA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a drilling function when an appropriate drill bit is inserted. It may include integral design features, e.g., have an angled head, be cannulated, have an attached Jacobs chuck, or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
006966006
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10649111501326Sklar Instruments31-40742026-03-12
10649111294235Sklar®67-10202016-10-07
40649111231422Sklar Instruments96-11302025-11-11
40649111233150Sklar Instruments96-11402025-11-11
40649111233501Sklar Instruments96-11422025-11-11
40649111233785Sklar Instruments96-11442025-11-11
40649111234102Sklar Instruments96-11462025-11-11
50649111095045Sklar Instruments94-02902025-06-15
50649111232921Sklar Instruments941-01922025-06-15
50649111344174Sklar Instruments941-09182025-06-15
50649111400115Sklar Instruments941-12592025-06-15
50649111400122Sklar Instruments941-12602025-06-15
50649111400139Sklar Instruments941-12612025-06-15
50649111447752Sklar Instruments941-15562025-06-15
50649111447912Sklar Instruments941-16132025-06-15
50649111469907Sklar Instruments941-13202025-06-15
50649111050402Sklar Instruments96-25162025-05-29
50649111050594Sklar Instruments96-25172025-05-29
50649111081109Sklar Instruments96-26802025-05-29
50649111081499Sklar Instruments96-26822025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B390030001131Reprocessed 2.3mm Lindemann ReamerSURETEK MEDICALHTT2025-07-18
08057717551020SHANNON STD BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551082SHANNON ISHAM BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551143CONICAL BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551204CONICAL BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551266CYLINDRICAL STRAIGHT BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551327CYLINDRICAL STRAIGHT BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551389CYLINDRICAL STRAIGHT BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551457WEDGE BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551525WEDGE BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551587ROUNDED BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551648ROUNDED BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551709BROPHY BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717550962SHANNON SHORT BURRBRM EXTREMITIES SRLHTT2025-03-27
B504OM0228013S0BrasselerProvisionHTT2025-02-05
B504OM030000170SynthesProvisionHTT2025-02-05
B504OM030000700SynthesProvisionHTT2025-02-05
B504OM03228015S0BrasselerProvisionHTT2025-02-05
B504OM03228017S0BrasselerProvisionHTT2025-02-05
B504OM04C03060BrasselerProvisionHTT2024-08-08
B504OM5300107140StrykerProvisionHTT2024-08-08
B504OM5300309010StrykerProvisionHTT2024-08-08
B504OM58200800210StrykerProvisionHTT2024-08-08
00840124512801FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCHTT2024-06-27
B504OMAR300B1010ArthrexProvisionHTT2024-06-10
B504OM5300105070StrykerProvisionHTT2024-05-28
B504OM13750520ConMedProvisionHTT2024-05-22
B504OM13750530ConMedProvisionHTT2024-05-22
B504OMDW311055R0VilexProvisionHTT2024-05-22
B504OM50911020ConMedProvisionHTT2024-05-16