FDA.reportPublic FDA data

restor3d Disposable Instrument Kit

Primary DI
00840097504872
Brand
restor3d Disposable Instrument Kit
Company
Restor3d
Model
4110-S013
Device description
Cervical Trial Kit with Stop, Large Footprint, 5-10mm Height, 7 degree
Published
2022-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097504872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097504872008400975048728400975048720840097504872

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840097509914restor3d Kinos Axiom PSR 5831-90032023-09-27
00840097509921restor3d Kinos Axiom PSR 5831-90042023-09-27
00840097509938restor3d Kinos Axiom PSR 5831-90052023-09-27
00840097509945restor3d Kinos Axiom PSR 5831-90062023-09-27
00840097508900Kinos Axiom Instrumentation5801-41095801.41092023-07-19
00840097508917Kinos Axiom Instrumentation5801-41055801.41052023-07-19
00840097507507Kinos Axiom Instrumentation5801-00505801.00502023-07-18
00840097507514Kinos Axiom Instrumentation5801-00515801.00512023-07-18
00840097507521Kinos Axiom Instrumentation5801-00525801.00522023-07-18
00840097509471Kinos Axiom Instrumentation5801-00185801.00182023-07-18
00840097509488Kinos Axiom Instrumentation5801-00195801.00192023-07-18
00840097509495Kinos Axiom Instrumentation5801-00205801.00202023-07-18
00840097509501Kinos Axiom Instrumentation5801-00215801.00212023-07-18
00840097509518Kinos Axiom Instrumentation5801-00222023-07-18
00840097509525Kinos Axiom Instrumentation5801-00325801.00322023-07-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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