DEVICE: Duraseal (20884521056388)

Device Identifier (DI) Information

Duraseal
206520
Not in Commercial Distribution

Covidien LP
20884521056388
GS1
February 21, 2023
1
058614483 *Terms of Use
Exact Spine Sealant System,
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
NQR Sealant, dural
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: less than 25 Degrees Celsius
Handling Environment Temperature: between 0 and 77 Degrees Fahrenheit
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Nominal inner volume content,5,Milliliter;
CLOSE

Device Record Status

afbb73f9-10a1-41b1-b07a-bd88a5311afa
June 24, 2025
8
September 22, 2014
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10884521056381 5 20884521056388 2023-02-21 Not in Commercial Distribution CASE
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(508)261-8000
covidien.udi@covidien.com
CLOSE