FDA.reportPublic FDA data

Sklar®

Primary DI
30649111379875
Brand
Sklar®
Company
SKLAR CORPORATION
Model
10-1965-12
Device description
PLASTC PRCDURE TRAY MIN PER 12
Published
2018-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30649111379875PrimaryGS10
00649111379874Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3064911137987530649111379875
00649111379874006491113798746491113798740649111379874

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument container systemA combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable surgical instruments between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers for the transportation of sterile surgical instruments from the central sterilization station to the operating room, and the reverse for soiled instruments to be decontaminated and sterilized; the soiled-instrument containers frequently including pre-soaking capabilities. Smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006966006
Device count
12
Premarket exempt
true
Lot or batch
true
Serial number
true
No natural rubber latex
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

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Primary DI, Brand, Company table
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07613327631876RPSSTRYKER CORPORATIONFSM2025-10-01
07613327681741N/ASTRYKER CORPORATIONFSM2025-09-03
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ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
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