Primary Device ID | B707125355750 |
NIH Device Record Key | d3522775-4a4f-44df-8f6c-a7bf3bff28a8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DUALX DUAL PORT HEMOSTATIC AGENT DELIVERY TUBE (USA) |
Version Model Number | 12535575 |
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 | 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 | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B707125355750 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
[B707125355750]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-03 |
Device Publish Date | 2024-03-26 |
B707125355750 | HEMOSTATIC AGENT DELIVERY TUBE |
B707125355860 | HEMOSTATIC AGENT DELIVERY TUBE US MANUFACTURE |