FDA.reportPublic FDA data

Sklar®

Primary DI
50649111278288
Brand
Sklar®
Company
SKLAR CORPORATION
Model
10-1104
Device description
Disposable CSR Sterilization Wrap
Published
2016-10-25
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
FRGWrap, sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931202000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931202000STERILIZATION WRAP-STERISHEETArjo Wiggins Medical, Inc.1993-12-16FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50649111278288PrimaryGS10
00649111278283Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5064911127828850649111278288
00649111278283006491112782836491112782830649111278283

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization container linerA non-sterile device intended to be used to line containers used for steam or solvent sterilization (e.g., trays, wraps, pouches) to absorb moisture and protect the container's finish. It is typically made of an absorbent, non-woven material or paper. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006966006
Device count
250
Lot or batch
true
Serial number
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
00840456206881JMUJMU DENTAL, INCFRG2026-07-08
00840456206898JMUJMU DENTAL, INCFRG2026-07-08
00840456206928JMUJMU DENTAL, INCFRG2026-07-08
10686864061868MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061875MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061899MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061905MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061912MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061929MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
00850072625867Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572025Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572032Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572049Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572056Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572063Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572070Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00842942013485PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013645PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013652PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013669PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013676PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013683PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014888PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014895PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014901PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014918PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014970PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014987PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014994PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015007PRIMEDpriMED Medical Products IncFRG2026-06-04