AccessGUDID - DEVICE: ORBIT GALAXY ENPOWER (10878528009426)

GUDID

Device Identifier (DI) Information

Brand Name: ORBIT GALAXY ENPOWER
Version or Model: 641CF0201
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 641CF0201
Company Name: Medos International Sàrl

Primary DI Number: 10878528009426
Issuing Agency: GS1
Commercial Distribution End Date: December 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil 2mm x 1.5cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Complex Fill Coil

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
HCG	DEVICE, NEUROVASCULAR EMBOLIZATION
KRD	Device, Vascular, for Promoting 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
Handling Environment Temperature: between 0 and 45 Degrees Celsius
Storage Environment Temperature: between 0 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a8d17d61-d2bf-4711-bcc2-8fece8e4dfc4
Public Version Date: November 30, 2023
Public Version Number: 5
DI Record Publish Date: September 20, 2015