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ExAblate 2100V1 Pelvic RF Coil 1.5T

FDA UDI

Class III (US FDA UDI)

by Insightec

Identity

Trade Name
ExAblate 2100V1 Pelvic RF Coil 1.5T FDA UDI
Generic Name
Therapeutic oncological/gynaecological ultrasound system FDA UDI
Device Name
ExAblate 2100V1 PHASE ARRAY ASSY Pelvic RF Coil for 1.5T MRI imaging during Body FUS treatments. Contains Upper and Lower part: ASM000426-AA - UPPER PELVIC COIL PHASE ARRAY ASSY ASC001361 - LOWER PELVIC COIL PHASE ARRAY ASSY for ExAblate 2100V1 FDA UDI
Model / Reference
OPT000037 ExAblate 2100V1 Pelvic RF Coil for Body FDA UDI
Description
ExAblate 2100V1 PHASE ARRAY ASSY Pelvic RF Coil for 1.5T MRI imaging during Body FUS treatments. Contains Upper and Lower part: ASM000426-AA - UPPER PELVIC COIL PHASE ARRAY ASSY ASC001361 - LOWER PELVIC COIL PHASE ARRAY ASSY for ExAblate 2100V1 FDA UDI

Identifiers

Catalog Number
OPT000037 FDA UDI
Primary DI / UDI-DI
07290015461474 FDA UDI
FDA Product Code
NRZ FDA UDI
LSY FDA UDI
GMDN Term
Therapeutic oncological/gynaecological ultrasound system FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Therapeutic oncological/gynaecological ultrasound system

ExAblate 2100V1 Pelvic RF Coil 1.5T by Insightec — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Therapeutic oncological/gynaecological ultrasound system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Insightec

Sources (1)

  • FDA UDI f9e494ea-c6e0-4bae-8ba4-6986f361fc2e 36 fields · synced Jun 1, 2026