FDA.reportPublic FDA data

Sklar

Primary DI
10649111033711
Brand
Sklar
Company
SKLAR CORPORATION
Model
10-1536TAA
Device description
TUMBLER 7 OZ 2 7/8 X 3 1/8 IN
Published
2019-09-13
Public version status
New
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
10649111033711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911103371110649111033711

GMDN Terms#

Term, Definition table
TermDefinition
Medicine cup, reusableA cup specially designed for administering medicine to patients or disabled persons. It will typically be made of stainless steel or durable plastic materials and will typically have graduated markings to facilitate providing specific doses of medication. It may be used both for tablets and fluids. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
006966006
Device count
1
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
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
07630055307736ACE Acetabular Reamer Tray - Instrument TrayIncipio Devices SAFSM2026-04-30
07613327652765TPXSTRYKER CORPORATIONFSM2026-03-25
07613327631852RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631869RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631876RPSSTRYKER CORPORATIONFSM2025-10-01
07613327681741N/ASTRYKER CORPORATIONFSM2025-09-03
ESAM23080001STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080161STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6550401STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
07630894802683APTUSMedartis AGFSM2023-02-24
07630894802973APTUSMedartis AGFSM2023-02-24
07630894802980APTUSMedartis AGFSM2023-02-24
07630894802997APTUSMedartis AGFSM2023-02-24
07630894803208APTUSMedartis AGFSM2023-02-24
07630894803215APTUSMedartis AGFSM2023-02-24
07630894803222APTUSMedartis AGFSM2023-02-24
07630894803246APTUSMedartis AGFSM2023-02-24
07630894803260APTUSMedartis AGFSM2023-02-24
07630894803307APTUSMedartis AGFSM2023-02-24
07630894803314APTUSMedartis AGFSM2023-02-24
07630894803321APTUSMedartis AGFSM2023-02-24
07630894803338APTUSMedartis AGFSM2023-02-24
07630894803345APTUSMedartis AGFSM2023-02-24
07630894803369APTUSMedartis AGFSM2023-02-24
07630894803383APTUSMedartis AGFSM2023-02-24
07630894803390APTUSMedartis AGFSM2023-02-24
07630894803413APTUSMedartis AGFSM2023-02-24