Primary Device ID | B487EXINF9120000 |
NIH Device Record Key | abdfeb1f-f70b-4ab1-af5d-10c98abee077 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | InFrame Instrument Kit |
Version Model Number | EXINF912000 |
Catalog Number | EXINF912000 |
Company DUNS | 116722111 |
Company Name | Exsomed Corporation |
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 | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
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 |
---|---|
HIBCC | B487EXINF9120000 [Primary] |
HXI | Passer, Wire, Orthopedic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-09-08 |
Device Publish Date | 2021-08-31 |
B487EXINN9215060 - NanoPhix Implant | 2024-02-01 NanoPhix is a stainless steel bone screw. |
B487EXINN9215070 - NanoPhix Implant | 2024-02-01 NanoPhix is a stainless steel bone screw. |
B487EXINN9215080 - NanoPhix Implant | 2024-02-01 NanoPhix is a stainless steel bone screw. |
B487EXINN9215090 - NanoPhix Implant | 2024-02-01 NanoPhix is a stainless steel bone screw. |
B487EXINN9215100 - NanoPhix Implant | 2024-02-01 NanoPhix is a stainless steel bone screw. |
B487EXINN9215110 - NanoPhix Implant | 2024-02-01 NanoPhix is a stainless steel bone screw. |
B487EXINN9215120 - NanoPhix Implant | 2024-02-01 NanoPhix is a stainless steel bone screw. |
B487EXINN9215130 - NanoPhix Implant | 2024-02-01 NanoPhix is a stainless steel bone screw. |