AccessGUDID - DEVICE: ULTRA Detach (00818053029639)

GUDID

Device Identifier (DI) Information

Brand Name: ULTRA Detach
Version or Model: ULTRA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BALT USA LLC

Primary DI Number: 00818053029639
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 945543689 *Terms of Use

Device Description: The ULTRA Detachment Controller is used in conjunction with the Prestige Coil System and separates the coils from the pusher system.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
60637	Vascular implant detacher, electronic, single-use	A noninvasive, hand-held, electrically-powered unit intended to deliver a low-level electric current to break the connection between a vascular implantable device (typically a neurovascular or peripheral embolization coil or stent) and its deployment device (i.e., implant inserter or delivery wire) via an electrolytic reaction. It is intended to connect to the proximal end of an appropriate implant inserter (delivery wire) which conducts the current to the electrically-unstable detachment point. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCG	Device, Neurovascular Embolization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: Store at a controlled room temperature in a dry place.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1c67e385-1c02-4c19-994a-974eabeccec6
Public Version Date: May 03, 2023
Public Version Number: 2
DI Record Publish Date: December 09, 2022