Primary Device ID | 00840097532196 |
NIH Device Record Key | 25779936-a440-4af9-8f6a-0aa4412466e5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ossera™ AFX |
Version Model Number | 1744-5274-N |
Company DUNS | 080819836 |
Company Name | Restor3d, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
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 | 00840097532196 [Primary] |
SAI | Ankle Fusion Cage |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840097532196]
Moist Heat or Steam Sterilization
[00840097532196]
Moist Heat or Steam Sterilization
[00840097532196]
Moist Heat or Steam Sterilization
[00840097532196]
Moist Heat or Steam Sterilization
[00840097532196]
Moist Heat or Steam Sterilization
[00840097532196]
Moist Heat or Steam Sterilization
[00840097532196]
Moist Heat or Steam Sterilization
[00840097532196]
Moist Heat or Steam Sterilization
[00840097532196]
Moist Heat or Steam Sterilization
[00840097532196]
Moist Heat or Steam Sterilization
[00840097532196]
Moist Heat or Steam Sterilization
[00840097532196]
Moist Heat or Steam Sterilization
[00840097532196]
Moist Heat or Steam Sterilization
[00840097532196]
Moist Heat or Steam Sterilization
[00840097532196]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-05-29 |
Device Publish Date | 2025-05-21 |
00840097513744 - restor3d Anatomic Bone Model | 2025-05-30 Anatomic Bone Model |
00840097522708 - restor3d Guidewire | 2025-05-30 Guidewire, Single Trocar, 1.6mm x 5" |
00840097513782 - Ossera™ AFX | 2025-05-29 Cannulated Convex Reamer, Ø28 |
00840097517766 - Ossera™ AFX | 2025-05-29 Ossera™ AFX, Half Pill, 34x34 |
00840097517773 - Ossera™ AFX | 2025-05-29 Ossera™ AFX, Half Pill, 34x36 |
00840097517780 - Ossera™ AFX | 2025-05-29 Ossera™ AFX, Half Pill, 34x38 |
00840097517797 - Ossera™ AFX | 2025-05-29 Ossera™ AFX, Half Pill, 34x40 |
00840097517803 - Ossera™ AFX | 2025-05-29 Ossera™ AFX, Half Pill, 34x42 |