FDA.reportPublic FDA data

4WEB Medical

Primary DI
00812998054428
Brand
4WEB Medical
Company
4web Medical
Model
ATS-020000-01
Catalog number
ATS-020000-01
Published
2024-11-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812998054428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812998054428008129980544288129980544280812998054428

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
021323706
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008129980540084WEB MedicalATS-020000-05ATS-020000-052024-11-22
008129980540154WEB MedicalATS-020000-06ATS-020000-062024-11-22
008129980540224WEB MedicalATS-020000-07ATS-020000-072024-11-22
008129980540394WEB MedicalATS-020000-08ATS-020000-082024-11-22
008129980540464WEB MedicalATS-020000-09ATS-020000-092024-11-22
008129980540534WEB MedicalATS-020000-10ATS-020000-102024-11-22
008100747560134WEB Medical4WEB-0000074WEB-0000072023-02-09
008129980522574WEB MedicalCSTS2-MD1206-SPCSTS2-MD1206-SP2026-04-28
008129980568284WEB MedicalLSTS-SM0608-MS2LSTS-SM0608-MS22026-04-07
008129980568354WEB MedicalLSTS-SM0610-MS2LSTS-SM0610-MS22026-04-07
008129980568424WEB MedicalLSTS-SM0612-MS2LSTS-SM0612-MS22026-04-07
008129980568594WEB MedicalLSTS-SM1208-MS2LSTS-SM1208-MS22026-04-07
008129980568664WEB MedicalLSTS-SM1210-MS2LSTS-SM1210-MS22026-04-07
008129980568734WEB MedicalLSTS-SM1212-MS2LSTS-SM1212-MS22026-04-07
008129980568804WEB MedicalLSTS-MD0608-MS2LSTS-MD0608-MS22026-04-07
008129980568974WEB MedicalLSTS-MD0610-MS2LSTS-MD0610-MS22026-04-07
008129980569034WEB MedicalLSTS-MD0612-MS2LSTS-MD0612-MS22026-04-07
008129980569104WEB MedicalLSTS-MD1208-MS2LSTS-MD1208-MS22026-04-07
008129980569274WEB MedicalLSTS-MD1210-MS2LSTS-MD1210-MS22026-04-07
008129980569344WEB MedicalLSTS-MD1212-MS2LSTS-MD1212-MS22026-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286860086Consensus Knee SystemShalby Advanced Technologies, Inc.FSM2026-07-09
03661219436522LANDANGERLANDANGERMDM2026-07-08
03661219436584LANDANGERLANDANGERMDM2026-07-08
03661219436706LANDANGERLANDANGERMDM2026-07-08
M697X07900081Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.FSM2026-07-08
00840456220283JMUJMU DENTAL, INCFSM2026-07-07
00190446907466EF1Medshape, Inc.FSM2026-06-25
00190446907473EF1Medshape, Inc.FSM2026-06-25
04054462915583evonosevonos GmbH & Co. KGMDM2026-06-25
00190776421724MillenniumAvalign Technologies, Inc.FSM2026-06-24
00198506091612ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
00198506091629ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
00885556924730EVOSSmith & Nephew, Inc.FSM2026-06-24
00810158211179PRINCETONPrinceton Medical Group, Inc.MDM2026-06-23
00840456200308JMUJMU DENTAL, INCFSM2026-06-23
00840456200315JMUJMU DENTAL, INCFSM2026-06-23
00840456201176JMUJMU DENTAL, INCFSM2026-06-23
00840456201206JMUJMU DENTAL, INCFSM2026-06-23
00840456201213JMUJMU DENTAL, INCFSM2026-06-23
00840456201220JMUJMU DENTAL, INCFSM2026-06-23
00840456201237JMUJMU DENTAL, INCFSM2026-06-23
00840456201244JMUJMU DENTAL, INCFSM2026-06-23
00840456201251JMUJMU DENTAL, INCFSM2026-06-23
00840456201268JMUJMU DENTAL, INCFSM2026-06-23
00840456206706JMUJMU DENTAL, INCFSM2026-06-23
00840456206713JMUJMU DENTAL, INCFSM2026-06-23
00840456207000JMUJMU DENTAL, INCFSM2026-06-23
00840456214077JMUJMU DENTAL, INCFSM2026-06-23
00840456214084JMUJMU DENTAL, INCFSM2026-06-23
00840456214091JMUJMU DENTAL, INCFSM2026-06-23