FDA.reportPublic FDA data

Sklar

Primary DI
30649111317778
Brand
Sklar
Company
SKLAR CORPORATION
Model
24-1014
Device description
MICHEL CLIPS 14MM (UNIT 1000)
Published
2019-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FZQCLIP, REMOVABLE (SKIN)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZQClip, Removable (Skin)General, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30649111317778PrimaryGS10
00649111317777Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3064911131777830649111317778
00649111317777006491113177776491113177770649111317777

GMDN Terms#

Term, Definition table
TermDefinition
Scalp wound clipA small, nonimplantable device in the form of a U-shaped clip that is fired from a dedicated scalp-clip applier (clip gun) or manually applied using dedicated scalp clip forceps, to approximate the margins of a scalp wound/incision associated with a surgical intervention on the cranium/scalp. It is made of metal or plastic materials and is typically applied in rows; it is intended to remain in place until the incision has healed. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
006966006
Device count
1000
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
00842331160783Novo Surgical Inc. NOVO SURGICAL, INC.FZQ2022-11-13
00842331163944Novo Surgical Inc. NOVO SURGICAL, INC.FZQ2022-11-13
20653405037238REFLEXConmed CorporationFZQ2021-10-14
20653405037252REFLEXConmed CorporationFZQ2021-10-14
20653405047091CONMED REFLEXConmed CorporationFZQ2021-10-14
00653405037234REFLEXConmed CorporationFZQ2021-10-14
00653405037258REFLEXConmed CorporationFZQ2021-10-14
30653405047098CONMED REFLEXConmed CorporationFZQ2021-10-14
00850010207094BandGrip® Micro-Anchor® Skin ClosureBANDGRIP INC.FZQ2021-03-01
00850010207193BandGrip® Micro-Anchor® Skin ClosureBANDGRIP INC.FZQ2021-03-01
10850010207091BandGrip® Micro-Anchor® Skin ClosureBANDGRIP INC.FZQ2021-03-01
20653405036927REFLEXConmed CorporationFZQ2020-11-13
20653405036958REFLEXConmed CorporationFZQ2020-11-13
20653405036989REFLEXConmed CorporationFZQ2020-11-13
20653405037016REFLEXConmed CorporationFZQ2020-11-13
20653405048388REFLEXConmed CorporationFZQ2020-11-13
20653405050596REFLEXConmed CorporationFZQ2020-11-13
20653405050602REFLEXConmed CorporationFZQ2020-11-13
20653405050893REFLEXConmed CorporationFZQ2020-11-13
10653405036920REFLEXConmed CorporationFZQ2020-11-13
10653405036951REFLEXConmed CorporationFZQ2020-11-13
10653405036982REFLEXConmed CorporationFZQ2020-11-13
10653405037019REFLEXConmed CorporationFZQ2020-11-13
10653405048381REFLEXConmed CorporationFZQ2020-11-13
10653405050599REFLEXConmed CorporationFZQ2020-11-13
10653405050605REFLEXConmed CorporationFZQ2020-11-13
10653405050896REFLEXConmed CorporationFZQ2020-11-13
04046826020392MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826020408MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826020415MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24