Primary Device ID | B707128450050 |
NIH Device Record Key | b66f7e7e-9578-47b1-98f8-37824863853c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DualXS Fixed ACME Drawbar Long |
Version Model Number | 12845005 |
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 |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B707128450050 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B707128450050]
Moist Heat or Steam Sterilization
[B707128450050]
Moist Heat or Steam Sterilization
[B707128450050]
Moist Heat or Steam Sterilization
[B707128450050]
Moist Heat or Steam Sterilization
[B707128450050]
Moist Heat or Steam Sterilization
[B707128450050]
Moist Heat or Steam Sterilization
[B707128450050]
Moist Heat or Steam Sterilization
[B707128450050]
Moist Heat or Steam Sterilization
[B707128450050]
Moist Heat or Steam Sterilization
[B707128450050]
Moist Heat or Steam Sterilization
[B707128450050]
Moist Heat or Steam Sterilization
[B707128450050]
Moist Heat or Steam Sterilization
[B707128450050]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-08-18 |
Device Publish Date | 2023-08-10 |
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B707129410010050 - DUALXS T/PLIF 12 DEG x 7-10MM | 2024-06-28 Lordosis & Heights: 8° x 7-10mm Collapsed Width (mm): 12 Expanded Width (mm): 20 Collapsed Height (mm): 7 Expanded Height (mm): |
B707129410010120 - DUALXS T/PLIF 15 DEG x 8-11MM | 2024-06-28 Lordosis & Heights: 15° x 8-11mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Height (mm): 8 Expanded Height (mm) |
B707125355750 - DUALX DUAL PORT HEMOSTATIC AGENT DELIVERY TUBE (USA) | 2024-04-03 HEMOSTATIC AGENT DELIVERY TUBE |
B707125355830010 - DUALX DUAL PORT CANNULA 30MM (USA) | 2024-04-03 30MM |
B707125355830020 - DUALX DUAL PORT CANNULA 40MM (USA) | 2024-04-03 40MM |
B707125355830030 - DUALX DUAL PORT CANNULA 50MM (USA) | 2024-04-03 50MM |
B707125355830040 - DUALX DUAL PORT CANNULA 60MM (USA) | 2024-04-03 60MM |