Primary Device ID | 08971460020315 |
NIH Device Record Key | 3b888f91-e9ea-499e-9b77-8295d9c41187 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Adherus AutoSpray ET Dural Sealant |
Version Model Number | NUS-109 |
Company DUNS | 145235953 |
Company Name | HYPERBRANCH MEDICAL TECHNOLOGY, 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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 9194333325 |
info@hyperbranch.com |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08971460020308 [Primary] |
GS1 | 08971460020315 [Package] Contains: 08971460020308 Package: [5 Units] In Commercial Distribution |
NQR | Sealant, Dural |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-10-23 |
Device Publish Date | 2016-12-19 |
08971460020315 | Adherus AutoSpray Extended Tip (ET) Dural Sealant is a sterile, single-use, electromechanical, b |
30897146002026 | Adherus AutoSpray Extended Tip (ET) Dural Sealant is a sterile, single-use, electromechanical, b |