Primary Device ID | 08800021124226 |
NIH Device Record Key | ae1170b7-a6b6-4d1a-8183-a867fa676ccc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FRT-5.2/5.9 |
Version Model Number | FRT-5.2/5.9 |
Catalog Number | FRT-5.2/5.9 |
Company DUNS | 694484789 |
Company Name | MCT Bio |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
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 | false |
OTC Over-The-Counter | false |
Phone | +82313337373 |
mct@mctbio.com | |
Phone | +82313337373 |
mct@mctbio.com | |
Phone | +82313337373 |
mct@mctbio.com | |
Phone | +82313337373 |
mct@mctbio.com | |
Phone | +82313337373 |
mct@mctbio.com | |
Phone | +82313337373 |
mct@mctbio.com | |
Phone | +82313337373 |
mct@mctbio.com | |
Phone | +82313337373 |
mct@mctbio.com | |
Phone | +82313337373 |
mct@mctbio.com | |
Phone | +82313337373 |
mct@mctbio.com | |
Phone | +82313337373 |
mct@mctbio.com | |
Phone | +82313337373 |
mct@mctbio.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08800021124226 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800021124226]
Moist Heat or Steam Sterilization
[08800021124226]
Moist Heat or Steam Sterilization
[08800021124226]
Moist Heat or Steam Sterilization
[08800021124226]
Moist Heat or Steam Sterilization
[08800021124226]
Moist Heat or Steam Sterilization
[08800021124226]
Moist Heat or Steam Sterilization
[08800021124226]
Moist Heat or Steam Sterilization
[08800021124226]
Moist Heat or Steam Sterilization
[08800021124226]
Moist Heat or Steam Sterilization
[08800021124226]
Moist Heat or Steam Sterilization
[08800021124226]
Moist Heat or Steam Sterilization
[08800021124226]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-15 |
Device Publish Date | 2024-07-05 |
08800021123144 - Adapter-1 | 2024-07-25 Adapter 1 Adapter for ratchet |
08800021123168 - Adapter-A | 2024-07-25 Adapter-A Adapter for handpiece |
08800021123175 - Adapter-H | 2024-07-25 Adapter-H IMPLANT-RESCUE-ADAPT Adapter for hand BONE-EXPAND-HP-ADAPT |
08800021123243 - BEC-2.6 | 2024-07-25 Bone Expander Tip ø2.6 BONE-EXPAND-2.6-TIP |
08800021123267 - BEC-3.4 | 2024-07-25 Bone Expander Tip ø3.4 BONE-EXPAND-3.4-TIP |
08800021123274 - BEC-3.8 | 2024-07-25 Bone Expander Tip ø3.8 BONE-EXPAND-3.8-TIP |
08800021123281 - BEC-4.3 | 2024-07-25 Bone Expander Tip ø4.3 BONE-EXPAND-4.3-TIP |
08800021124097 - FRW-01 | 2024-07-25 Remover Wrench BONE-EXPANDER-WRENCH |