FDA.reportPublic FDA data

Kyocera Medical Technologies, Inc.

Primary DI
00841523130078
Brand
Kyocera Medical Technologies, Inc.
Company
KYOCERA MEDICAL TECHNOLOGIES, INC.
Model
S 128
Catalog number
3129-001-007
Device description
34 x 28 Implant Caddy, 12° PEEK
Published
2016-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00841523130078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841523130078008415231300788415231300780841523130078

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
116995646
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841523181360Kyocera Medical Technologies, Inc.Tesera-k PL2171-001-0012026-05-26
00841523181681Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1072026-05-26
00841523181698Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1082026-05-26
00841523181704Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1092026-05-26
00841523181711Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1102026-05-26
00841523181728Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1112026-05-26
00841523181735Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1122026-05-26
00841523181742Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1132026-05-26
00841523181759Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1142026-05-26
00841523181766Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1152026-05-26
00841523181773Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1162026-05-26
00841523181780Kyocera Medical Technologies, Inc.Tesera-k PL2171-229-1072026-05-26
00841523181797Kyocera Medical Technologies, Inc.Tesera-k PL2171-229-1082026-05-26
00841523181803Kyocera Medical Technologies, Inc.Tesera-k PL2171-229-1092026-05-26
00841523181810Kyocera Medical Technologies, Inc.Tesera-k PL2171-229-1102026-05-26
00841523181827Kyocera Medical Technologies, Inc.Tesera-k PL2171-229-1112026-05-26
00841523181834Kyocera Medical Technologies, Inc.Tesera-k PL2171-229-1122026-05-26
00841523181841Kyocera Medical Technologies, Inc.Tesera-k PL2171-229-1132026-05-26
00841523181858Kyocera Medical Technologies, Inc.Tesera-k PL2171-229-1142026-05-26
00841523181865Kyocera Medical Technologies, Inc.Tesera-k PL2171-229-1152026-05-26

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