Adherus AutoSpray ET Dural Sealant

GUDID 30897146002026

Adherus AutoSpray Extended Tip (ET) Dural Sealant is a sterile, single-use, electromechanical, battery operated device with internal system components that provide air flow to aid in the delivery of a synthetic, absorbable, two-component hydrogel sealant system and allow delivery to be interrupted without clogging.

HYPERBRANCH MEDICAL TECHNOLOGY, INC.

Dura mater sealant
Primary Device ID30897146002026
NIH Device Record Key3b888f91-e9ea-499e-9b77-8295d9c41187
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdherus AutoSpray ET Dural Sealant
Version Model NumberNUS-109
Company DUNS145235953
Company NameHYPERBRANCH MEDICAL TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9194333332
Emailrob.naslund@stryker.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100897146002025 [Primary]
GS130897146002026 [Package]
Contains: 00897146002025
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQRSealant, Dural

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-03
Device Publish Date2016-12-19

On-Brand Devices [Adherus AutoSpray ET Dural Sealant]

08971460020315Adherus AutoSpray Extended Tip (ET) Dural Sealant is a sterile, single-use, electromechanical, b
30897146002026Adherus AutoSpray Extended Tip (ET) Dural Sealant is a sterile, single-use, electromechanical, b

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.