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ULTRA Detach

FDA UDI

Class II (US FDA UDI)

by Balt Usa Llc

Identity

Trade Name
ULTRA Detach FDA UDI
Generic Name
Vascular implant detacher, electronic, single-use FDA UDI
Device Name
The ULTRA Detachment Controller is used in conjunction with the Prestige Coil System and separates the coils from the pusher system. FDA UDI
Model / Reference
ULTRA FDA UDI
Description
The ULTRA Detachment Controller is used in conjunction with the Prestige Coil System and separates the coils from the pusher system. FDA UDI

Identifiers

Primary DI / UDI-DI
00818053024351 FDA UDI
FDA Product Code
HCG FDA UDI
GMDN Term
Vascular implant detacher, electronic, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5950 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Vascular implant detacher, electronic, single-use

ULTRA Detach by Balt Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular implant detacher, electronic, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Balt Usa Llc

Sources (1)

  • FDA UDI 235e1e54-186f-40c2-a06c-f10945840c8b 35 fields · synced Jun 8, 2026