FDA.report

restor3d Disposable Trial Kit

Primary DI
00840097508702
Brand
restor3d Disposable Trial Kit
Company
Restor3d
Model
4100-0101
Device description
Cotton Kit
Published
2023-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840097508702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097508702008400975087028400975087020840097508702

GMDN Terms

TermDefinition
Surgical implant/trial-implant/sizer holder, single-useA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080819836
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00840097509921restor3d Kinos Axiom PSR 5831-90042023-09-27
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00840097505251Kinos Axiom Instrumentation5801-00132023-06-28
00840097505275Kinos Axiom Instrumentation5801-00142023-06-28
00840097507491Kinos Axiom Instrumentation5801-00472023-05-23
00840097504377Kinos Axiom Instrumentation5801-00922023-05-19
00840097504483Kinos Axiom Instrumentation5801-00462023-05-19

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