Primary Device ID | 07612334216571 |
NIH Device Record Key | 37d4618b-01f0-49e9-9c0a-0aed11c576ed |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | 03.164.004 |
Catalog Number | 03164004 |
Company DUNS | 486711679 |
Company Name | Synthes GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 |
Phone | +1(800)255-2500 |
xx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07612334216571 [Direct Marking] |
GS1 | 10886982311016 [Primary] |
HWT | TEMPLATE |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07612334216571]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-07 |
Device Publish Date | 2022-11-29 |
10886982344229 - NA | 2024-05-13 FOOT - 10MM UPRIGHT REDUCTION CLAMP |
10886982344236 - NA | 2024-05-13 FOOT - 4MM UPRIGHT REDUCTION CLAMP |
10886982344243 - NA | 2024-05-13 HOOK - 4MM UPRIGHT REDUCTION CLAMP |
10886982344250 - NA | 2024-05-13 HOOK - 10MM UPRIGHT REDUCTION CLAMP |
10886982346940 - NA | 2024-05-09 60MM DEPTH PROBE FOR XL25 SCREWS |
10886982346933 - NA | 2024-05-08 EXTENDED MULTI HOLE WIRE GUIDE FOR RFNA |
10886982346957 - NA | 2024-05-08 FNS ANGLED GUIDE 130° W/ WIDER BASE |
10887587078359 - NA | 2024-04-16 MANDIBLE BODY REDUCTION HANDLE |