Primary Device ID | 07613327019360 |
NIH Device Record Key | f2bfa9a0-86a1-40df-99eb-84fbc2c74863 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Restoration |
Version Model Number | S-2651-1016 |
Catalog Number | S-2651-1016 |
Company DUNS | 058311945 |
Company Name | Howmedica Osteonics Corp. |
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 | 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 Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07613327019360 [Primary] |
LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2015-09-24 |
07613327140927 | ADM Insert |
07613327140903 | ADM Insert |
07613327140897 | ADM Insert |
07613327140880 | ADM Insert |
07613327140873 | ADM Insert |
07613327140866 | ADM Insert |
07613327140842 | ADM Insert |
07613327140828 | ADM Insert |
07613327140804 | ADM Insert |
07613327140781 | ADM Insert |
07613327037173 | Plate Screw |
07613327037166 | Plate Screw |
07613327037159 | Plate Screw |
07613327037142 | Plate Screw |
07613327037135 | Plate Screw |
07613327037128 | Plate Screw |
07613327037111 | Plate Screw |
07613327037104 | Plate Screw |
07613327037098 | Plate Screw |
07613327037081 | Plate Screw |
07613327019872 | Acetabular Wedge Augment |
07613327019865 | Acetabular Wedge Augment |
07613327019858 | Acetabular Wedge Augment |
07613327019841 | Acetabular Wedge Augment |
07613327019834 | Acetabular Wedge Augment |
07613327019827 | Acetabular Wedge Augment |
07613327019810 | Acetabular Wedge Augment |
07613327019803 | Acetabular Wedge Augment |
07613327019797 | Acetabular Wedge Augment |
07613327019780 | Acetabular Wedge Augment |
07613327019773 | Acetabular Wedge Augment |
07613327019766 | Acetabular Wedge Augment |
07613327019759 | Acetabular Wedge Augment |
07613327019742 | Acetabular Wedge Augment |
07613327019735 | Acetabular Wedge Augment |
07613327019728 | Acetabular Wedge Augment |
07613327019711 | Acetabular Wedge Augment |
07613327019704 | Acetabular Wedge Augment |
07613327019551 | Hip Stem |
07613327019544 | Hip Stem |
07613327019537 | Hip Stem |
07613327019520 | Hip Stem |
07613327019513 | Hip Stem |
07613327019506 | Hip Stem |
07613327019490 | Hip Stem |
07613327019483 | Hip Stem |
07613327019476 | Hip Stem |
07613327019469 | Hip Stem |
07613327019452 | Hip Stem |
07613327019445 | Hip Stem |