FDA.reportPublic FDA data

Wexler Surgical, Inc.

Primary DI
M944TL044710
Brand
Wexler Surgical, Inc.
Company
WEXLER SURGICAL, INC.
Model
TL0447.1
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M944TL044710PrimaryHIBCC0
00840240937403SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840240937403008402409374038402409374030840240937403

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
024882552
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M944FL051010Wexler Surgical, Inc.FL0510.12026-10-30
M944SL712210Wexler Surgical, Inc.SL7122.12026-10-30
M944SL712410Wexler Surgical, Inc.SL7124.12026-10-30
M944SL712510Wexler Surgical, Inc.SL7125.12026-10-30
M944TL034010Wexler Surgical, Inc.TL0340.12026-10-30
M944TL034110Wexler Surgical, Inc.TL0341.12026-10-30
M944TL034210Wexler Surgical, Inc.TL0342.12026-10-30
M944TL034310Wexler Surgical, Inc.TL0343.12026-10-30
M944TL034410Wexler Surgical, Inc.TL0344.12026-10-30
M944TL034510Wexler Surgical, Inc.TL0345.12026-10-30
M944TL034610Wexler Surgical, Inc.TL0346.12026-10-30
M944TL034710Wexler Surgical, Inc.TL0347.12026-10-30
M944TL034810Wexler Surgical, Inc.TL0348.12026-10-30
M944TL034910Wexler Surgical, Inc.TL0349.12026-10-30
M944TL036110Wexler Surgical, Inc.TL0361.12026-10-30
M944TL044610Wexler Surgical, Inc.TL0446.12026-10-30
M944TL072010Wexler Surgical, Inc.TL0720.12026-10-30
M944TL072210Wexler Surgical, Inc.TL0722.12026-10-30
M944TL845110Wexler Surgical, Inc.TL8451.12026-10-30
M944TL845210Wexler Surgical, Inc.TL8452.12026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M944TL034010Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034110Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034210Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034310Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034410Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034510Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034610Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034710Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034810Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034910Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL036110Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL044610Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL072010Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL072210Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
B382SD903260200Surgical DirectSurgical Direct, Inc.DWS2026-10-28
00724995264819Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264826Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264833Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264840Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264857Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265564Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265571Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265588Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995278977V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279004V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279042V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279059V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279066V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279080V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280093V. MuellerSTERIS Deutschland GmbHDWS2026-10-27