Primary Device ID | 08806390874267 |
NIH Device Record Key | e193e24b-37e5-4293-8870-ca9862844eab |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ARIX Ankle System Bone Plate |
Version Model Number | 35V-DLF2-007-L |
Company DUNS | 688811603 |
Company Name | Jeil Medical Corporation |
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 | 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 | 08806390874267 [Primary] |
HRS | Plate, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08806390874267]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-04-03 |
Device Publish Date | 2020-03-26 |
08806390874274 | 35V-DLF2-008-L |
08806390874267 | 35V-DLF2-007-L |
08806390874250 | 35V-DLF2-006-L |
08806390874243 | 35V-DLF2-005-L |
08806390874236 | 35V-DLF2-004-L |
08806390874229 | 35V-DLF2-003-L |
08806390874212 | 35V-DLF2-008-R |
08806390874205 | 35V-DLF2-007-R |
08806390874199 | 35V-DLF2-006-R |
08806390874182 | 35V-DLF2-005-R |
08806390874175 | 35V-DLF2-004-R |
08806390874168 | 35V-DLF2-003-R |
08800089434343 | 35V-DLF3-008-R |
08800089434336 | 35V-DLF3-008-L |
08800089434329 | 35V-DLF3-007-R |
08800089434312 | 35V-DLF3-007-L |
08800089434305 | 35V-DLF3-006-R |
08800089434299 | 35V-DLF3-006-L |
08800089434282 | 35V-DLF3-005-R |
08800089434275 | 35V-DLF3-005-L |
08800089434268 | 35V-DLF3-004-R |
08800089434251 | 35V-DLF3-004-L |
08800089434244 | 35V-DLF3-003-R |
08800089434237 | 35V-DLF3-003-L |