FDA.report

Kyocera Medical Technologies, Inc.

Primary DI
00841523121069
Brand
Kyocera Medical Technologies, Inc.
Company
KYOCERA MEDICAL TECHNOLOGIES, INC.
Model
S 100
Catalog number
2101-453-000
Device description
4.5mm Tap
Published
2016-09-24
Public version status
Update
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
00841523121069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841523121069008415231210698415231210690841523121069

GMDN Terms

TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. 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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