Primary Device ID | B707128310000090 |
NIH Device Record Key | 68b45d93-5bb0-4d6f-a9a8-f430aa935249 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DUALX LLIF 10-13MM x 12 DEG x 55MM |
Version Model Number | 12831000009 |
Company DUNS | 081021000 |
Company Name | AMPLIFY SURGICAL, INC. |
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 | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B707128310000090 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-04-08 |
Device Publish Date | 2021-03-31 |
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