FDA.reportPublic FDA data

4WEB Medical

Primary DI
00810074759793
Brand
4WEB Medical
Company
4web Medical
Model
PSTS-000310-R
Catalog number
PSTS-000310-R
Published
2023-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810074759793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810074759793008100747597938100747597930810074759793

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
008129980544284WEB MedicalATS-020000-01ATS-020000-012024-11-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091353ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091407ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091209ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-03
00810130456406Medco ManufacturingMedco Manufacturing LLCMDM2026-06-02
00846338007126Endiscope and accessoriesELLIQUENCE, LLCMDM2026-06-02
00846338005429DilatorELLIQUENCE, LLCMDM2026-06-01
06932503510219Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
06932503510226Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
B356KE392100American MedicalsAmerican MedicalsMDM2026-05-29
B356KE396100American MedicalsAmerican MedicalsMDM2026-05-29
08800042700102Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700140Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700256Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700270Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700287Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700300Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700317Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700324Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700386Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700393Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700416Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700423Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700843Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700850Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700874Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700881Artisential Precise Needle HolderLIVSMEDMDM2026-04-29