FDA.report

4WEB Medical

Primary DI
00810074757713
Brand
4WEB Medical
Company
4web Medical
Model
CSTS-PS-010000-02
Catalog number
CSTS-PS-010000-02
Published
2023-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications

CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810074757713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810074757713008100747577138100747577130810074757713

GMDN Terms

TermDefinition
Internal spinal fixation procedure kit, reusableA collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

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

Other Devices From This Company

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008129980526844WEB Medical4WEB-OA51S-LV1254WEB-OA51S-LV1252026-01-22
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008129980527524WEB Medical4WEB-OA51S-SV2054WEB-OA51S-SV2052026-01-22
008129980527694WEB Medical4WEB-OA51S-SLV1254WEB-OA51S-SLV1252026-01-22
008129980528064WEB Medical4WEB-OA51S-SSV1254WEB-OA51S-SSV1252026-01-22
008129980528204WEB Medical4WEB-OA51S-SSV2054WEB-OA51S-SSV2052026-01-22
008129980528444WEB Medical4WEB-OA51S-P1254WEB-OA51S-P1252026-01-22
008129980528754WEB Medical4WEB-OA51S-P2054WEB-OA51S-P2052026-01-22
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
008129980557534WEB Medical4WEB-LAS-BLD-SS1504WEB-LAS-BLD-SS1502026-01-22
008129980557604WEB Medical4WEB-LAS-BLD-SS1604WEB-LAS-BLD-SS1602026-01-22
008129980526464WEB Medical4WEB-OA51S-H1254WEB-OA51S-H1252026-01-21

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