AccessGUDID - DEVICE: Adherus AutoSpray Dural Sealant (00897146002018)

GUDID

Device Identifier (DI) Information

Brand Name: Adherus AutoSpray Dural Sealant
Version or Model: NUS-106
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HYPERBRANCH MEDICAL TECHNOLOGY, INC.

Primary DI Number: 00897146002018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 145235953 *Terms of Use

Device Description: Adherus AutoSpray 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47171	Dura mater sealant	An implanted bioabsorbable material (e.g., solution, gel, spray, patch) intended to be applied to a defect in the dura mater, possibly as an adjunct to standard methods of closure (e.g., suturing), to prevent cerebrospinal fluid (CSF) leakage during healing. The material primarily consists of synthetic polymers that subsequently form adhesive bonds with the dura mater and eventually degrade and are absorbed. After application, this device cannot be reused.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NQR	Sealant, Dural

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P130014	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ce233010-f961-4ee7-a0d4-2c2bb733cd44
Public Version Date: April 03, 2020
Public Version Number: 4
DI Record Publish Date: April 14, 2015