FDA.report

4WEB Medical

Primary DI
00810074751063
Brand
4WEB Medical
Company
4web Medical
Model
CSTS-SA-000031
Catalog number
CSTS-SA-000031
Published
2021-10-11
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
00810074751063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810074751063008100747510638100747510630810074751063

GMDN Terms

TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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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