| Primary Device ID | 08800021124134 |
| NIH Device Record Key | b7b90204-9751-4a21-bb63-cdd40ac828cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SRG-SH |
| Version Model Number | SRG-SH |
| Catalog Number | SRG-SH |
| 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 | |
| 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 | 08800021124134 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800021124134]
Moist Heat or Steam Sterilization
[08800021124134]
Moist Heat or Steam Sterilization
[08800021124134]
Moist Heat or Steam Sterilization
[08800021124134]
Moist Heat or Steam Sterilization
[08800021124134]
Moist Heat or Steam Sterilization
[08800021124134]
Moist Heat or Steam Sterilization
[08800021124134]
Moist Heat or Steam Sterilization
[08800021124134]
Moist Heat or Steam Sterilization
[08800021124134]
Moist Heat or Steam Sterilization
[08800021124134]
Moist Heat or Steam Sterilization
[08800021124134]
Moist Heat or Steam Sterilization
[08800021124134]
Moist Heat or Steam Sterilization
[08800021124134]
Moist Heat or Steam Sterilization
[08800021124134]
Moist Heat or Steam Sterilization
[08800021124134]
Moist Heat or Steam Sterilization
[08800021124134]
Moist Heat or Steam Sterilization
[08800021124134]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-26 |
| Device Publish Date | 2024-07-18 |
| 08800021124066 - SRA-01 | 2024-07-26 Screw Remove Adapter, IMPLANT RESCUE-SRA-1 |
| 08800021124127 - SRG-IO | 2024-07-26 Screw Remover Guide IO (O) IMPLANT RESCUE-OCTA |
| 08800021124134 - SRG-SH | 2024-07-26Screw Remover Guide SH (H), IMPLANT-RESCUE-HEX |
| 08800021124134 - SRG-SH | 2024-07-26 Screw Remover Guide SH (H), IMPLANT-RESCUE-HEX |
| 08800021124141 - SRG-H | 2024-07-26 Screw Remover Guide handle, IMPLANT-GUIDE-TOOL |
| 08800021124301 - SRG-3IN | 2024-07-26 Screw Remover Guide 3i Internal NP (3i-N) IMPLANT RESCUE-31-NP |
| 08800021124325 - SRG-NAN | 2024-07-26 Screw Remover Guide Nobel Active NP (Nobel-N) IMPLANT RESCUE-NACN |
| 08800021124332 - SRG-NAN | 2024-07-26 Screw Remover Guide Nobel Active RP (Nobel-R) IMPLANT RESCUE-NACR |
| 08800021124356 - SRG-NTR | 2024-07-26 Screw Remover Guide Nobel Replace Tri-Lobe RP (Tri-Lobe RP), IMPLANT RESCUE-TRI-R |