FDA.reportPublic FDA data

4WEB Medical

Primary DI
00812998021826
Brand
4WEB Medical
Company
4web Medical
Model
CSTS-010102
Published
2018-12-21
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
MDMInstrument, Manual, Surgical, General Use
OJHOrthopedic Tray

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121741000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1217410004-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)4-Web, Inc.2012-10-18ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812998021826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812998021826008129980218268129980218260812998021826

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument container systemA combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable surgical instruments between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers for the transportation of sterile surgical instruments from the central sterilization station to the operating room, and the reverse for soiled instruments to be decontaminated and sterilized; the soiled-instrument containers frequently including pre-soaking capabilities. Smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters. 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
008129980366464WEB MedicalASTS-MD1216-LPASTS-MD1216-LP2020-07-17
008129980366534WEB MedicalASTS-MD1216-LPASTS-MD1216-LP2020-07-17
008129980264564WEB MedicalASTS-LG1210-LPASTS-LG1210-LP2018-12-14
008129980264634WEB MedicalASTS-LG1212-LPASTS-LG1212-LP2018-12-14
008129980264874WEB MedicalASTS-LG0610-LPASTS-LG0610-LP2018-12-14
008129980264944WEB MedicalASTS-LG0612-LPASTS-LG0612-LP2018-12-14
008129980265004WEB MedicalASTS-LG0614-LPASTS-LG0614-LP2018-12-14
008129980265174WEB MedicalASTS-MD1210-LPASTS-MD1210-LP2018-12-14
008129980265244WEB MedicalASTS-MD1212-LPASTS-MD1212-LP2018-12-14
008129980265314WEB MedicalASTS-MD1214-LPASTS-MD1214-LP2018-12-14
008129980346974WEB MedicalASTS-MD1210-LP-SASTS-MD1210-LP-S2018-12-14
008129980347034WEB MedicalASTS-MD1212-LP-SASTS-MD1212-LP-S2018-12-14
008129980347104WEB MedicalASTS-MD1214-LP-SASTS-MD1214-LP-S2018-12-14
008129980347274WEB MedicalASTS-LG0610-LP-SASTS-LG0610-LP-S2018-12-14
008129980347344WEB MedicalASTS-LG0612-LP-SASTS-LG0612-LP-S2018-12-14
008129980347414WEB MedicalASTS-LG0614-LP-SASTS-LG0614-LP-S2018-12-14
008129980347584WEB MedicalASTS-LG1210-LP-SASTS-LG1210-LP-S2018-12-14
008129980347654WEB MedicalASTS-LG1212-LP-SASTS-LG1212-LP-S2018-12-14
008129980358544WEB MedicalASTS-MD1216-LP-SASTS-MD1216-LP-S2018-12-14
008129980540084WEB MedicalATS-020000-05ATS-020000-052024-11-22

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