AccessGUDID - DEVICE: DuraSeal® (10381780000013)

GUDID

Device Identifier (DI) Information

Brand Name: DuraSeal®
Version or Model: 202010DS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 202010DS
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780000013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: DuraSeal® Dural Sealant System Polymer Kit

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 [?]
P040034	024

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Nominal inner volume content 5 Millimeter

Device Record Status

Public Device Record Key: 54655176-3f0a-42de-b87b-eff91bc20e25
Public Version Date: April 14, 2023
Public Version Number: 8
DI Record Publish Date: June 05, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)654-2873
Email: custsvcnj@integralife.com

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