FDA.reportPublic FDA data

Sklar

Primary DI
30649111260388
Brand
Sklar
Company
SKLAR CORPORATION
Model
10-1539-12
Device description
PITCHER BEAKER W/HANDLE PK/12
Published
2019-08-02
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
30649111260388PrimaryGS10
00649111260387Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3064911126038830649111260388
00649111260387006491112603876491112603870649111260387

GMDN Terms#

Term, Definition table
TermDefinition
General laboratory container, reusableA container (e.g., test tube, bottle, cup, assay tray with large wells) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), biological specimens, and other materials associated with in the laboratory; it is not intended for in vitro diagnostic procedures. It is designed to withstand an extremely high-temperature environment (e.g., autoclaving) to enable repeated sterilization. It is typically made of high-temperature-resistant plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers (e.g., tissue culture). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
006966006
Device count
12
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
B382SD923300150Surgical DirectSurgical Direct, Inc.FSM2026-08-07
B382SD923301040Surgical DirectSurgical Direct, Inc.FSM2026-08-07
00840606192002Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192019Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192026Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192033Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192040Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194884Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194891Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194907Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194914Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194921Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194938Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194945Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194952Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194969Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194976Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194983Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194990Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195003Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195010Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195027Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195034Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195041Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195058Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195065Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195539Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195669Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195676Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195683Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31