restor3d Reusable Instrument Tray

Primary DI
00840097502076
Brand
restor3d Reusable Instrument Tray
Company
Restor3d
Model
5000-0401
Device description
Instrument Tray, Osteotomy Wedge System
Published
2019-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097502076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097502076008400975020768400975020760840097502076

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080819836
Device count
1
DM exempt
true
Premarket exempt
false
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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

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