AccessGUDID - DEVICE: CraniSeal Dural Sealant (00860010683705)

GUDID

Device Identifier (DI) Information

Brand Name: CraniSeal Dural Sealant
Version or Model: CS-2055
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CS-2055
Company Name: Pramand LLC

Primary DI Number: 00860010683705
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 117587283 *Terms of Use

Device Description: The CraniSeal Dural Sealant is indicated for use in patients greater than or equal to 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide a watertight closure.

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 [?]
P220014	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: between 0 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 5 Milliliter

Device Record Status

Public Device Record Key: fc4212d9-12f7-4b2f-960c-7cab3d5c9d00
Public Version Date: February 05, 2025
Public Version Number: 4
DI Record Publish Date: August 15, 2023