FDA.reportPublic FDA data

Sklar

Primary DI
40649111442378
Brand
Sklar
Company
SKLAR CORPORATION
Model
21-982
Device description
EXPLORER OCT HNDL SE SIZE 23 BX12
Published
2019-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EKBEXPLORER, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKBExplorer, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40649111442378PrimaryGS10
00649111442370Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4064911144237840649111442378
00649111442370006491114423706491114423700649111442370

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical probe, reusableA slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
006966006
Device count
12
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
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
10649111229817Sklar Instruments96-11202025-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB2010TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2020TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2030TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2040TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2050TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3010TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3020TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3030TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3040TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3050TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3060TBS BASICSACME ENTERPRISE.EKB2026-05-16
10889950002916HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010027HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010034HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010041HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010058HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010799HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010805HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010812HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010829HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010836HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010843HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010850HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010867HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010874HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010881HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010898HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010904HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010911HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010928HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12