FDA.reportPublic FDA data

Sklar®

Primary DI
40649111341053
Brand
Sklar®
Company
SKLAR CORPORATION
Model
31-7300
Device description
LIGATION CLIPS SM 120BX STER
Published
2017-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FZPCLIP, IMPLANTABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZPClip, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111930000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111930000ACKERMANN EUROPCLIPAckermann Instrumente GmbH2011-11-08FZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40649111341053PrimaryGS10
00649111341055Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4064911134105340649111341053
00649111341055006491113410556491113410550649111341055

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006966006
Device count
120
Lot or batch
true
Serial number
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
14026704936882WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936899WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936905WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936912WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936929WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936936WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936943WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936950WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936967WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936974WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936981WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936998WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704935779WECKTELEFLEX INCORPORATEDFZP2026-08-15
14026704935786WECKTELEFLEX INCORPORATEDFZP2026-08-15
14026704935809WECKTELEFLEX INCORPORATEDFZP2026-08-15
14026704935823WECKTELEFLEX INCORPORATEDFZP2026-08-15
14026704935847WECKTELEFLEX INCORPORATEDFZP2026-08-15
14026704725424WECKTELEFLEX INCORPORATEDFZP2026-08-01
00198506092794ELMED INCORPORATEDELMED INCORPORATEDFZP2026-07-28
04717480902064InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902101InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902149InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902170InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902217InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902293InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
08904255203877MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203938MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203945MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203952MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225503MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18