FDA.report

Sklar®

Primary DI
40649111115890
Brand
Sklar®
Company
SKLAR CORPORATION
Model
21-778
Device description
ADSON-BROWN TISS SD GRASP BX12
Published
2018-12-14
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

Related Records

Product Codes

CodeName
GENFORCEPS, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40649111115890PrimaryGS10
00649111115892Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
4064911111589040649111115890
00649111115892006491111158926491111158920649111115892

GMDN Terms

TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method

Regulatory Flags

DUNS number
006966006
Device count
12
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
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
00190776417925MillenniumAvalign Technologies, Inc.GEN2026-03-23
00190776417963MillenniumAvalign Technologies, Inc.GEN2026-03-23
00190776418045MillenniumAvalign Technologies, Inc.GEN2026-03-23
00190776418052MillenniumAvalign Technologies, Inc.GEN2026-03-23
24026704941555PILLINGTELEFLEX INCORPORATEDGEN2026-03-23
24026704941562PILLINGTELEFLEX INCORPORATEDGEN2026-03-23
24026704941579PILLINGTELEFLEX INCORPORATEDGEN2026-03-23
24026704941609PILLINGTELEFLEX INCORPORATEDGEN2026-03-23
00192896122949Deluxe Alligator Grasping ForcepsSONTEC INSTRUMENTS, INC.GEN2026-03-19
04046826492632MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGEN2026-03-19
04046826492649MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGEN2026-03-19
G453FA06160PEAK MEDICALPeak Medical Distribution Inc.GEN2026-03-19
00190776417703MillenniumAvalign Technologies, Inc.GEN2026-03-11
00190776417819MillenniumAvalign Technologies, Inc.GEN2026-03-11
00840329836924Black & Black SurgicalBLACK & BLACK SURGICAL, INC.GEN2026-03-05
04058749036152NAFehling Instruments GmbH & Co. KGGEN2026-03-05
00198506088667ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-25
00198506088674ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-25
00198506088872ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-25
00198506088476ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-23
00198506088742ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-23
00190776416713MillenniumAvalign Technologies, Inc.GEN2026-02-20
00810130207350MSIModern Surgical Instruments LLCGEN2026-02-20
B382SD6720680Surgical DirectSurgical Direct, Inc.GEN2026-02-17
B382SD6720690Surgical DirectSurgical Direct, Inc.GEN2026-02-17
00190776416508MillenniumAvalign Technologies, Inc.GEN2026-02-16
B382SD49129280Surgical DirectSurgical Direct, Inc.GEN2026-02-16
B382SD6522210Surgical DirectSurgical Direct, Inc.GEN2026-02-16
B382SD6536480Surgical DirectSurgical Direct, Inc.GEN2026-02-16
03662663129046Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCGEN2026-02-11