FDA.reportPublic FDA data

4WEB Medical

Primary DI
00810074753753
Brand
4WEB Medical
Company
4web Medical
Model
LSTS-000302-R
Catalog number
LSTS-000302-R
Published
2021-10-04
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
LXHOrthopedic Manual Surgical Instrument
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810074753753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810074753753008100747537538100747537530810074753753

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system, reusableA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. 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

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