AccessGUDID - DEVICE: ORBIT GALAXY XTRASOFT (10886704030546)

GUDID

Device Identifier (DI) Information

Brand Name: ORBIT GALAXY XTRASOFT
Version or Model: 640CX0202
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 640CX0202
Company Name: Medos International Sàrl

Primary DI Number: 10886704030546
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: ORBIT GALAXY Detachable Coil System 175cm 2mm 2cm Contents: 1 detachable coil system and 1 luer valve. Coil Type: Complex Xtrasoft Note: ONLY use with TRUFILL DCS Syringe II

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?
17846	Vascular guide-catheter, single-use	A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.	Active	false

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 [?]
K093973	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: 8f9173e4-e4b6-461c-be02-1318f36019b2
Public Version Date: December 22, 2021
Public Version Number: 7
DI Record Publish Date: September 20, 2015