AccessGUDID - DEVICE: CGuard Prime Carotid Stent System (07290120281707)

GUDID

Device Identifier (DI) Information

Brand Name: CGuard Prime Carotid Stent System
Version or Model: CND0840
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CND0840
Company Name: INSPIRE M.D LTD

Primary DI Number: 07290120281707
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514477996 *Terms of Use

Device Description: CGuard Prime Carotid Stent System 135cm, 8mmx40mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
61563	Mesh-sleeve carotid artery stent	A non-bioabsorbable tubular device wrapped in a flexible fine mesh dedicated to implantation in a carotid artery to improve its luminal diameter in patients with atherosclerotic carotid artery disease. It consists of a metal framework with a polymeric mesh sleeve, typically intended to prevent restenosis. The stent is intended to be inserted and expanded using a balloon catheter. Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NIM	Stent, Carotid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P240029	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a7088b55-99c6-4539-af30-b3258719dfe8
Public Version Date: July 10, 2025
Public Version Number: 1
DI Record Publish Date: July 02, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
07290120281905	1	07290120281707		In Commercial Distribution

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: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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