AccessGUDID - DEVICE: Duraseal (20884521056432)

GUDID

Device Identifier (DI) Information

Brand Name: Duraseal
Version or Model: 20-2050
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 20884521056432
Issuing Agency: GS1
Commercial Distribution End Date: December 16, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Dural Sealant System,

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 [?]
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: less than 77 Degrees Fahrenheit
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: 69eeeba6-a334-4c35-9e7a-fe380fcf099b
Public Version Date: December 20, 2024
Public Version Number: 6
DI Record Publish Date: September 22, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10884521056435	5	20884521056432	2024-12-16	Not in Commercial Distribution	CASE

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(508)261-8000
Email: covidien.udi@covidien.com

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