FDA.reportPublic FDA data

Sklar®

Primary DI
50649111322844
Brand
Sklar®
Company
SKLAR CORPORATION
Model
96-1744
Published
2016-11-23
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
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971062000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971062000OPPORTUNITY INC. GENERAL PURPOSE TRAYOpportunity, Inc.1997-06-09LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50649111322844PrimaryGS10
00649111322849Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5064911132284450649111322844
00649111322849006491113228496491113228490649111322849

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006966006
Device count
10
Lot or batch
true
Serial number
true
No natural rubber latex
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
10809160542323HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542330HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542347HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542354HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542361HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542378HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542385HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542392HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542408HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542422HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542446HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542453HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542460HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542477HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542484HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542507HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542514HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542521HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542538HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542545HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542552HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542569HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542576HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542583HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542590HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542606HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542620HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542637HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542644HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542651HalyardAVID MEDICAL, INC.LRO2026-11-02