Primary Device ID | 00889024485655 |
NIH Device Record Key | 6c40fcd9-bbd7-4598-ba13-60d902b68658 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Anatomical Shoulder™ Fracture |
Version Model Number | 01.04237.180 |
Company DUNS | 488133448 |
Company Name | Zimmer GmbH |
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 | 00889024485655 [Primary] |
HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
[00889024485655]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 6 |
Public Version Date | 2019-04-08 |
Device Publish Date | 2017-02-27 |
00889024485686 | AS FX Alignment rod |
00889024485679 | AS FX Handle for rasp |
00889024485662 | AS FX Screw for rasp |
00889024485655 | AS FX Spring for rasp |
00889024287242 | AS FX Alignment rod |
00889024287167 | AS FX Handle for rasp |
00889024287150 | AS FX Screw for rasp |
00889024287136 | AS FX Spring for rasp |
00889024387171 | Humeral trial head Ø52 right |
00889024387164 | Humeral trial head Ø52 left |
00889024387157 | Humeral trial head Ø40 right - slim |
00889024387140 | Humeral trial head Ø40 left - slim |
00889024387133 | Humeral trial head Ø36 right - slim |
00889024387126 | Humeral trial head Ø36 left - slim |
00889024387119 | Assembly block / Adapter |
00889024387102 | Rasp extension 18.5 [17ce] |
00889024387096 | Rasp extension 16.5 [17pf/15ce] |
00889024387089 | Rasp 19.5 [18ce] |
00889024387072 | Rasp 18.5 [17ce] |
00889024387065 | Rasp 17.5 [18pf/16ce] |
00889024387058 | Rasp 16.5 [17pf/15ce] |
00889024387041 | Rasp 9.5 [8ce] slim |
00889024387034 | Rasp 8.5 [7ce] slim |
00889024387027 | Rasp 7.5 [8pf/6ce] slim |
00889024387010 | Rasp 6.5 [7pf/5ce] slim |
00889024387003 | Rasp 5.5 [6pf] slim |
00889024386990 | Rasp 4.5 [5pf] slim |
00889024287365 | AS FX Holding Forceps |
00889024287358 | AS FX Control rod |
00889024287341 | AS FX Ruler |
00889024287310 | AS FX Screw for humeral trial head |
00889024287303 | AS FX Humeral trial head, right 48 |
00889024287297 | AS FX Humeral trial head, left 48 |
00889024287280 | AS FX Humeral trial head, right 44 |
00889024287273 | AS FX Humeral trial head, left 44 |
00889024287266 | AS FX Humeral trial head, right 40 |
00889024287259 | AS FX Humeral trial head, left 40 |
00889024287129 | AS FX Rasp 15.5 |
00889024287112 | AS FX Rasp extension 14.5 |
00889024287105 | AS FX Rasp 14.5 |
00889024287099 | AS FX Rasp 13.5 |
00889024287075 | AS FX Rasp extension 12.5 |
00889024287068 | AS FX Rasp 12.5 |
00889024287044 | AS FX Rasp 11.5 |
00889024287013 | AS FX Rasp extension 10.5 |
00889024287006 | AS FX Rasp 10.5 |
00889024286993 | AS FX Rasp 9.5 |
00889024286986 | AS FX Rasp extension 8.5 |
00889024286979 | AS FX Rasp 8.5 |
00889024286962 | AS FX Rasp 7.5 |