AccessGUDID - DEVICE: HELIPAQ (00878528002512)

GUDID

Device Identifier (DI) Information

Brand Name: HELIPAQ
Version or Model: HEL181630-20
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HEL18163020
Company Name: Medos International Sàrl

Primary DI Number: 00878528002512
Issuing Agency: GS1
Commercial Distribution End Date: December 30, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: HELIPAQ microcoil HELIPAQ 18 Platinum Coil 16mm x 30cm 190cm Contents: 1 Detachable Coil System

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?
60940	Neurovascular embolization coil	A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KRD	Device, Vascular, for Promoting Embolization
HCG	DEVICE, NEUROVASCULAR EMBOLIZATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142429	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
Special Storage Condition, Specify: Keep Dry
Storage Environment Temperature: between 32 and 110 Degrees Fahrenheit
Storage Environment Temperature: between 0 and 45 Degrees Celsius
Handling Environment Temperature: between 0 and 45 Degrees Celsius
Handling Environment Temperature: between 32 and 110 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e83019a8-7175-4c94-8995-bfd61c807883
Public Version Date: November 30, 2023
Public Version Number: 5
DI Record Publish Date: September 20, 2015