FDA.reportPublic FDA data

Sklar®

Primary DI
10649111139222
Brand
Sklar®
Company
SKLAR CORPORATION
Model
41-870
Device description
DE MCCALLS CURETTE #13S + 14S
Published
2018-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMKCURETTE, SURGICAL, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMKCurette, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10649111139222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911113922210649111139222

GMDN Terms#

Term, Definition table
TermDefinition
Dental curette, basicA hand-held dental instrument with a spoon-shaped working end designed to scrape oral tissues. 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
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
B382SD48800210Surgical DirectSurgical Direct, Inc.EMK2026-08-03
B382SD48800220Surgical DirectSurgical Direct, Inc.EMK2026-08-03
B382S344441010Surgical DirectSurgical Direct, Inc.EMK2026-07-31
B382SD914631720Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914631770Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914631780Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914631790Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914638200Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914638210Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD9146461000Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD9146531550Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD902511300Surgical DirectSurgical Direct, Inc.EMK2026-07-24
B382SD9143681000Surgical DirectSurgical Direct, Inc.EMK2026-07-13
00850083275532Intrace USAPILOTIS TECH LLCEMK2026-07-03
00841336106413Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2026-06-08
G149TBSB7900TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7910TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7920TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7930TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7940TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7950TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149NP380620NPSACME ENTERPRISE.EMK2026-05-01
G149NPSCL0NPSACME ENTERPRISE.EMK2026-05-01
10889950126339Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126346Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126353Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126360Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126377Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126384Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126391Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06