FDA.report

TiWAVE L Lumbar Cage System

Primary DI
B07323K0107100
Brand
TiWAVE L Lumbar Cage System
Company
Kalitec Direct LLC
Model
23-K01-0710
Device description
Tamp, Rotating
Published
2019-01-29
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
HXGTamp

Product Code Classifications

CodeDeviceSpecialtyClass
HXGTampOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B07323K0107100PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical tampA hand-held, surgical instrument used to pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of high-grade stainless steel, but some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure or by tapping the proximal end with a hammer/mallet. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
041956211
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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B07310BRS02300Cosmolock10-BRS-023010-BRS-02302024-01-16
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