Primary Device ID | 09348215038076 |
NIH Device Record Key | a3688e22-e64f-435f-95ed-7d30a34add33 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Trial UniPolar Head |
Version Model Number | 112-33-0012 |
Company DUNS | 751993028 |
Company Name | SIGNATURE ORTHOPAEDICS PTY LTD |
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 | false |
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 | 09348215038076 [Primary] |
HWT | Template |
KWL | Prosthesis, Hip, Hemi-, Femoral, Metal |
Steralize Prior To Use | true |
Device Is Sterile | false |
[09348215038076]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-06-18 |
Device Publish Date | 2018-10-02 |
09348215038229 | 112-33-0069 |
09348215038212 | 112-33-0068 |
09348215038205 | 112-33-0058 |
09348215038199 | 112-33-0057 |
09348215038182 | 112-33-0056 |
09348215038175 | 112-33-0055 |
09348215038168 | 112-33-0054 |
09348215038151 | 112-33-0053 |
09348215038144 | 112-33-0052 |
09348215038137 | 112-33-0051 |
09348215038120 | 112-33-0050 |
09348215038113 | 112-33-0049 |
09348215038106 | 112-33-0048 |
09348215038090 | 112-33-0014 |
09348215038083 | 112-33-0013 |
09348215038076 | 112-33-0012 |
09348215038069 | 112-33-0011 |
09348215038052 | 112-33-0010 |
09348215038045 | 112-33-0009 |
09348215038038 | 112-33-0008 |
09348215038021 | 112-33-0007 |