← Back to catalogue

TOTIM Patient Cushion Immobilization System

FDA UDI

Class II (US FDA UDI)

by Essebi Medical Srl

Identity

Trade Name
TOTIM Patient Cushion Immobilization System FDA UDI
Generic Name
Patient positioning foam mould kit FDA UDI
Model / Reference
TTM3002 JOLLY FDA UDI

Identifiers

Primary DI / UDI-DI
08058045280057 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Patient positioning foam mould kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Patient positioning foam mould kit

TOTIM Patient Cushion Immobilization System by Essebi Medical Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient positioning foam mould kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Essebi Medical Srl

Sources (1)

  • FDA UDI 82cf0dd6-ce8b-4bc0-8e5c-83d7d92aa6f5 32 fields · synced May 30, 2026