Primary Device ID | 09348215134563 |
NIH Device Record Key | 28f4c5e2-8900-4ca8-b01d-7d2fe861f6d1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Nebula Standard Offset Size 5 |
Version Model Number | 111-59-0005 |
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 | 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 |
---|---|
GS1 | 09348215134563 [Primary] |
OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-28 |
Device Publish Date | 2025-03-20 |
09348215122720 - Signasure World Insert | 2025-03-28 |
09348215134518 - Nebula Standard Offset Size 0 | 2025-03-28 |
09348215134525 - Nebula Standard Offset Size 1 | 2025-03-28 |
09348215134532 - Nebula Standard Offset Size 2 | 2025-03-28 |
09348215134549 - Nebula Standard Offset Size 3 | 2025-03-28 |
09348215134556 - Nebula Standard Offset Size 4 | 2025-03-28 |
09348215134563 - Nebula Standard Offset Size 5 | 2025-03-28 |
09348215134563 - Nebula Standard Offset Size 5 | 2025-03-28 |
09348215134570 - Nebula Standard Offset Size 6 | 2025-03-28 |