Primary Device ID | 00841523108145 |
NIH Device Record Key | dad90b55-1d36-4940-a80e-886fa68f2dd8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Kyocera Medical Technologies, Inc. |
Version Model Number | S 100 |
Catalog Number | 1103-753-035 |
Company DUNS | 116995646 |
Company Name | KYOCERA MEDICAL TECHNOLOGIES, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00841523108145 [Primary] |
KWP | Appliance, Fixation, Spinal Interlaminal |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00841523108145]
Moist Heat or Steam Sterilization
[00841523108145]
Moist Heat or Steam Sterilization
[00841523108145]
Moist Heat or Steam Sterilization
[00841523108145]
Moist Heat or Steam Sterilization
[00841523108145]
Moist Heat or Steam Sterilization
[00841523108145]
Moist Heat or Steam Sterilization
[00841523108145]
Moist Heat or Steam Sterilization
[00841523108145]
Moist Heat or Steam Sterilization
[00841523108145]
Moist Heat or Steam Sterilization
[00841523108145]
Moist Heat or Steam Sterilization
[00841523108145]
Moist Heat or Steam Sterilization
[00841523108145]
Moist Heat or Steam Sterilization
[00841523108145]
Moist Heat or Steam Sterilization
[00841523108145]
Moist Heat or Steam Sterilization
[00841523108145]
Moist Heat or Steam Sterilization
[00841523108145]
Moist Heat or Steam Sterilization
[00841523108145]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-07-30 |
Device Publish Date | 2015-10-29 |
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00841523130054 | 38 x 30 Implant Caddy, 7° PEEK |
00841523119851 | 9mm Trial, 34 X 28, 12° Lordosis |
00841523119844 | 9mm Trial, 30 X 26, 12° Lordosis |
00841523146079 | Tesera T, Straight Trial 28mm x 10mm x 16mm, Bullet |
00841523146062 | Tesera T, Straight Trial 28mm x 10mm x 15mm, Bullet |
00841523146055 | Tesera T, Straight Trial 28mm x 10mm x 14mm, Bullet |
00841523146048 | Tesera T, Straight Trial 28mm x 10mm x 13mm, Bullet |
00841523146031 | Tesera T, Straight Trial 28mm x 10mm x 12mm, Bullet |
00841523146024 | Tesera T, Straight Trial 28mm x 10mm x 11mm, Bullet |
00841523146017 | Tesera T, Straight Trial 28mm x 10mm x 10mm, Bullet |
00841523146000 | Tesera T, Straight Trial 28mm x 10mm x 9mm, Bullet |
00841523145997 | Tesera T, Straight Trial 28mm x 10mm x 8mm, Bullet |
00841523145980 | Tesera T, Straight Trial 28mm x 10mm x 7mm, Bullet |
00841523150625 | Pituitary Rongeur, 4mm x 10mm |
00841523150618 | Pituitary Rongeur, 4mm x 10mm |
00841523150601 | Posterior Paddle Sizer, 15mm |
00841523150595 | Posterior Paddle Sizer, 14mm |
00841523150588 | Posterior Paddle Sizer, 13mm |
00841523150571 | Posterior Paddle Sizer, 12mm |
00841523150564 | Posterior Paddle Sizer, 11mm |
00841523150557 | Posterior Paddle Sizer, 10mm |
00841523150540 | Posterior Paddle Sizer, 9mm |
00841523150533 | Posterior Paddle Sizer, 8mm |
00841523150526 | Posterior Paddle Sizer, 7mm |
00841523150519 | Posterior Paddle Sizer, 6mm |
00841523150502 | Tesera C Cage Inserter |
00841523150496 | Distal Femoral Cut Block |
00841523150489 | Distal Femoral Alignment Guide Tower |
00841523148622 | PS Box Gauge |
00841523148615 | A200 PS Notch Cutting Guide, Size 7 |
00841523148608 | A200 PS Notch Cutting Guide, Size 6 |
00841523148592 | A200 PS Notch Cutting Guide, Size 5 |
00841523148585 | A200 PS Notch Cutting Guide, Size 4 |
00841523148578 | A200 PS Notch Cutting Guide, Size 3 |
00841523148561 | A200 PS Notch Cutting Guide, Size 2 |
00841523148554 | A200 PS Notch Cutting Guide, Size 1 |
00841523147649 | PS Tibia Insert Trial Size C, 23mm - Right |
00841523147632 | PS Tibia Insert Trial Size C, 20mm - Right |
00841523147625 | PS Tibia Insert Trial Size C, 17mm - Right |
00841523147618 | PS Tibia Insert Trial Size C, 14mm - Right |
00841523147601 | PS Tibia Insert Trial Size C, 12mm - Right |
00841523147595 | PS Tibia Insert Trial Size C, 10mm - Right |
00841523147588 | PS Tibia Insert Trial Size B, 23mm - Right |
00841523147571 | PS Tibia Insert Trial Size B, 20mm - Right |
00841523147564 | PS Tibia Insert Trial Size B, 17mm - Right |
00841523147557 | PS Tibia Insert Trial Size B, 14mm - Right |
00841523147540 | PS Tibia Insert Trial Size B, 12mm - Right |
00841523147533 | PS Tibia Insert Trial Size B, 10mm - Right |
00841523147526 | PS Tibia Insert Trial Size A, 23mm - Right |