FDA.report

Kyocera Medical Technologies, Inc.

Primary DI
00841523172016
Brand
Kyocera Medical Technologies, Inc.
Company
KYOCERA MEDICAL TECHNOLOGIES, INC.
Model
TRIBRID Unicompartmental Knee System
Catalog number
3210-004-001
Device description
Tribrid Tibial Instruments Case Base
Published
2024-05-22
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841523172016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841523172016008415231720168415231720160841523172016

GMDN Terms

TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
116995646
Device count
1
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00841523184088Kyocera Medical Technologies, Inc.A 2001201-131-1112026-02-18
00841523184095Kyocera Medical Technologies, Inc.A 2001201-131-1132026-02-18
00841523184101Kyocera Medical Technologies, Inc.A 2001201-131-3112026-02-18
00841523184118Kyocera Medical Technologies, Inc.A 2001201-131-3132026-02-18
00841523184125Kyocera Medical Technologies, Inc.A 2001201-131-5112026-02-18
00841523184132Kyocera Medical Technologies, Inc.A 2001201-131-5132026-02-18
00841523184149Kyocera Medical Technologies, Inc.A 2001201-132-1112026-02-18
00841523184156Kyocera Medical Technologies, Inc.A 2001201-132-1132026-02-18
00841523184163Kyocera Medical Technologies, Inc.A 2001201-132-3112026-02-18
00841523184170Kyocera Medical Technologies, Inc.A 2001201-132-3132026-02-18
00841523184187Kyocera Medical Technologies, Inc.A 2001201-132-5112026-02-18
00841523184194Kyocera Medical Technologies, Inc.A 2001201-132-5132026-02-18
00841523184200Kyocera Medical Technologies, Inc.A 2001201-231-1112026-02-18
00841523184217Kyocera Medical Technologies, Inc.A 2001201-231-1132026-02-18
00841523184224Kyocera Medical Technologies, Inc.A 2001201-231-3112026-02-18
00841523184231Kyocera Medical Technologies, Inc.A 2001201-231-3132026-02-18
00841523184248Kyocera Medical Technologies, Inc.A 2001201-231-5112026-02-18
00841523184255Kyocera Medical Technologies, Inc.A 2001201-231-5132026-02-18
00841523184262Kyocera Medical Technologies, Inc.A 2001201-232-1112026-02-18
00841523184279Kyocera Medical Technologies, Inc.A 2001201-232-1132026-02-18

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