FDA.report

4WEB Medical

Primary DI
00810074751582
Brand
4WEB Medical
Company
4web Medical
Model
LSTS-100050
Catalog number
LSTS-100050
Published
2022-07-15
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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications

CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810074751582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810074751582008100747515828100747515820810074751582

GMDN Terms

TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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

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008129980527144WEB Medical4WEB-OA51S-LV2054WEB-OA51S-LV2052026-01-22
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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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