FDA.report

4WEB Medical

Primary DI
00810074751520
Brand
4WEB Medical
Company
4web Medical
Model
LSTS-PLT304-NS
Catalog number
LSTS-PLT304-NS
Published
2021-09-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications

CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810074751520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810074751520008100747515208100747515200810074751520

GMDN Terms

TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
021323706
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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008129980528064WEB Medical4WEB-OA51S-SSV1254WEB-OA51S-SSV1252026-01-22
008129980528204WEB Medical4WEB-OA51S-SSV2054WEB-OA51S-SSV2052026-01-22
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008129980556924WEB Medical4WEB-LAS-BLD-SS0904WEB-LAS-BLD-SS0902026-01-22
008129980557084WEB Medical4WEB-LAS-BLD-SS1004WEB-LAS-BLD-SS1002026-01-22
008129980557154WEB Medical4WEB-LAS-BLD-SS1104WEB-LAS-BLD-SS1102026-01-22
008129980557224WEB Medical4WEB-LAS-BLD-SS1204WEB-LAS-BLD-SS1202026-01-22
008129980557394WEB Medical4WEB-LAS-BLD-SS1304WEB-LAS-BLD-SS1302026-01-22
008129980557464WEB Medical4WEB-LAS-BLD-SS1404WEB-LAS-BLD-SS1402026-01-22
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