AccessGUDID - DEVICE: DuraSeal Exact Spinal Sealant System (10381780000037)

GUDID

Device Identifier (DI) Information

Brand Name: DuraSeal Exact Spinal Sealant System
Version or Model: 206320
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 206320
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780000037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: DuraSeal® Exact Spinal Sealant System 3mL 5 pack

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":	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

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
Handling Environment Temperature: between 0 and 77 Degrees Fahrenheit
Handling Environment Temperature: between 0 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Nominal inner volume content 3 Milliliter

Device Record Status

Public Device Record Key: 2971728d-3113-4f57-ae84-76432ac13765
Public Version Date: December 02, 2024
Public Version Number: 8
DI Record Publish Date: December 29, 2016