AccessGUDID - DEVICE: Caterpillar (00801741175565)

GUDID

Device Identifier (DI) Information

Brand Name: Caterpillar
Version or Model: CTP056030U
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CTP056030U
Company Name: CLEARSTREAM TECHNOLOGIES LIMITED

Primary DI Number: 00801741175565
Issuing Agency: GS1
Commercial Distribution End Date: December 07, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 989214291 *Terms of Use

Device Description: Caterpillar Arterial Embolization Device, 0.056 Inch ID Catheter Compatibility

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":	Yes
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?
61632	Non-neurovascular embolization plug, metallic	A non-bioabsorbable, metal device intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is in the form of an expandable metal scaffold, which once expanded is intended to induce thrombosis and create a blockage; it is typically supplied with instruments dedicated to implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KRD	Device, Vascular, for Promoting Embolization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191532	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
Device Size Text, specify: Marker to Marker Length, 18 Millimeter

Device Record Status

Public Device Record Key: fc917955-45aa-4474-b48e-84f9f11fa902
Public Version Date: April 17, 2024
Public Version Number: 3
DI Record Publish Date: February 10, 2020