FDA.reportPublic FDA data

Wexler Surgical, Inc.

Primary DI
M944DL20000
Brand
Wexler Surgical, Inc.
Company
WEXLER SURGICAL, INC.
Model
DL2000
Published
2017-11-29
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
M944DL20000PrimaryHIBCC0
00840240913049SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840240913049008402409130498402409130490840240913049

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for placing/containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
024882552
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M944VL040020Wexler Surgical, Inc.VL0400.22018-09-23
M944NL8606150Wexler Surgical, Inc.NL8606.152025-12-26
M944SHARB60Wexler Surgical, Inc.SHA-RB62025-10-10
M944SACRB3L0Wexler Surgical, Inc.SA-C-RB3L2025-08-22
M944SACRB4L0Wexler Surgical, Inc.SA-C-RB4L2025-08-22
M944SACRB50Wexler Surgical, Inc.SA-C-RB52025-08-22
M944SACRB60Wexler Surgical, Inc.SA-C-RB62025-08-22
00840240938202Wexler Surgical, Inc.SA-C-RB3L2025-08-22
00840240938219Wexler Surgical, Inc.SA-C-RB4L2025-08-22
00840240938226Wexler Surgical, Inc.SA-C-RB52025-08-22
M944SARB30Wexler Surgical, Inc.SA-RB32025-05-16
M944SARB40Wexler Surgical, Inc.SA-RB42025-05-16
M944SARB50Wexler Surgical, Inc.SA-RB52025-05-16
M944SARB60Wexler Surgical, Inc.SA-RB62025-05-16
M944SARB70Wexler Surgical, Inc.SA-RB72025-05-16
00840240938127Wexler Surgical, Inc.SA-RB32025-05-16
00840240938110Wexler Surgical, Inc.SA-RB42025-05-16
00840240938103Wexler Surgical, Inc.SA-RB52025-05-16
00840240938097Wexler Surgical, Inc.SA-RB62025-05-16
M944LAFM30Wexler Surgical, Inc.LA-FM32025-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630008405793APTUSMedartis AGFSM2026-07-16
07630008405809APTUSMedartis AGFSM2026-07-16
07630008405878APTUSMedartis AGFSM2026-07-16
07630008405892APTUSMedartis AGFSM2026-07-16
07630008406226APTUSMedartis AGFSM2026-07-16
07630008406233APTUSMedartis AGFSM2026-07-16
07630008406240APTUSMedartis AGFSM2026-07-16
07630008406257APTUSMedartis AGFSM2026-07-16
07630008406264APTUSMedartis AGFSM2026-07-16
07630008406271APTUSMedartis AGFSM2026-07-16
07630008406288APTUSMedartis AGFSM2026-07-16
07630008406295APTUSMedartis AGFSM2026-07-16
07630008406301APTUSMedartis AGFSM2026-07-16
07630008406318APTUSMedartis AGFSM2026-07-16
07630008406325APTUSMedartis AGFSM2026-07-16
07630008406332APTUSMedartis AGFSM2026-07-16
07630008428327APTUSMedartis AGFSM2026-07-16
07630008428334APTUSMedartis AGFSM2026-07-16
07630008453206APTUSMedartis AGFSM2026-07-16
07630008488284APTUSMedartis AGFSM2026-07-16
07630008488314APTUSMedartis AGFSM2026-07-16
07630008488406APTUSMedartis AGFSM2026-07-16
07630037833475APTUSMedartis AGFSM2026-07-16
07630037833482APTUSMedartis AGFSM2026-07-16
07630037846437APTUSMedartis AGFSM2026-07-16
07630037846444APTUSMedartis AGFSM2026-07-16
07630037846697APTUSMedartis AGFSM2026-07-16
07630037846802APTUSMedartis AGFSM2026-07-16
07630037847229APTUSMedartis AGFSM2026-07-16
07630037847236APTUSMedartis AGFSM2026-07-16