AccessGUDID - DEVICE: DuraFuse Dural Clip (00860007130403)

GUDID

Device Identifier (DI) Information

Brand Name: DuraFuse Dural Clip
Version or Model: DC-501
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Neuramedica Inc.

Primary DI Number: 00860007130403
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079885939 *Terms of Use

Device Description: NeuraMedica Dural Clips are bioabsorbable surgical clips designed to aid in closure of the dura mater in neurosurgical and orthopedic spine procedures. NeuraMedica Dural Clips are 3mm wide by 4.6mm long. They are applied using a reusable stainless steel applier. The NeuraMedica Applier is a separately-supplied reusable instrument.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
45413	Ligation clip, synthetic polymer, bioabsorbable	A bioabsorbable clasp intended to be implanted to ligate a vessel (e.g., blood, lymphatic, or other tube-like structure) that does not require permanent occlusion after the surgical procedure, as the device is gradually degraded and digested by body tissues. The device is typically made of a polymer (e.g., polydioxanone), and may be radiolucent; a dedicated, disposable clip applier may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FZP	Clip, Implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 61994351-c46f-47f1-b20d-aebc0f6376b2
Public Version Date: March 17, 2023
Public Version Number: 1
DI Record Publish Date: March 09, 2023