FDA.reportPublic FDA data

Sklar®

Primary DI
40649111104535
Brand
Sklar®
Company
SKLAR CORPORATION
Model
21-710
Device description
"DRESS FCP SERR 5"" BX12"
Published
2018-07-11
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
GENFORCEPS, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40649111104535PrimaryGS10
00649111104537Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4064911110453540649111104535
00649111104537006491111045376491111045370649111104537

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, tweezers-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is not intended for tissue manipulation. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is typically metallic and available in various sizes. This is a reusable device intended to be sterilized prior to use.

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
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
00190776437176MillenniumAvalign Technologies, Inc.GEN2026-10-28
00190776437183MillenniumAvalign Technologies, Inc.GEN2026-10-28
00190776437190MillenniumAvalign Technologies, Inc.GEN2026-10-28
00190776437206MillenniumAvalign Technologies, Inc.GEN2026-10-28
00190776437213MillenniumAvalign Technologies, Inc.GEN2026-10-28
B382SD88820Surgical DirectSurgical Direct, Inc.GEN2026-10-28
B382SD88829020Surgical DirectSurgical Direct, Inc.GEN2026-10-28
B382SD902547200Surgical DirectSurgical Direct, Inc.GEN2026-10-28
04250337119616Biopsy Forceps, SpoonJoimax GmbHGEN2026-10-27
04250337121954Biopsy Forceps, BlakesleyJoimax GmbHGEN2026-10-27
04250337121961Biopsy Forceps, SpoonJoimax GmbHGEN2026-10-26
04250337121978Biopsy Forceps, Spoon, angledJoimax GmbHGEN2026-10-26
00198506095863ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-23
00198506096310ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-23
00190776435646MillenniumAvalign Technologies, Inc.GEN2026-10-21
00190776435691MillenniumAvalign Technologies, Inc.GEN2026-10-21
00190776435745MillenniumAvalign Technologies, Inc.GEN2026-10-21
00190776436780MillenniumAvalign Technologies, Inc.GEN2026-10-21
00190776436810MillenniumAvalign Technologies, Inc.GEN2026-10-21
00190776435448MillenniumAvalign Technologies, Inc.GEN2026-10-19
00840329838669N/ABLACK & BLACK SURGICAL, INC.GEN2026-10-15
00190776435011MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776435035MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776434816MillenniumAvalign Technologies, Inc.GEN2026-10-13
00190776434779MillenniumAvalign Technologies, Inc.GEN2026-10-12
04058749012842NAFehling Instruments GmbH & Co. KGGEN2026-10-12
00190776434175MillenniumAvalign Technologies, Inc.GEN2026-10-09
00198506095801ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095818ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095825ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09