FDA.reportPublic FDA data

Wexler Surgical, Inc.

Primary DI
M944TL845410
Brand
Wexler Surgical, Inc.
Company
WEXLER SURGICAL, INC.
Model
TL8454.1
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
DRCTrocar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M944TL845410PrimaryHIBCC0
00840240938776SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840240938776008402409387768402409387760840240938776

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
M944TL044710Wexler Surgical, Inc.TL0447.12026-10-30
M944TL072010Wexler Surgical, Inc.TL0720.12026-10-30
M944TL072210Wexler Surgical, Inc.TL0722.12026-10-30
M944TL845110Wexler Surgical, Inc.TL8451.12026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M944TL845210Wexler Surgical, Inc.WEXLER SURGICAL, INC.DRC2026-10-30
00884450735916Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735906Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735920Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735944Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735968Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735975Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735999Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736033Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736057Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736071Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736118Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736132Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736149Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736187Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736224Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736262Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736309Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736361Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736385Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736439Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736446Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736491Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736507Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736552Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450739317Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450739348Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450739379Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
00810212933825SURGIPROSSurgipros, LLCDRC2026-07-28
00810212933832SURGIPROSSurgipros, LLCDRC2026-07-28