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GammaTile Radiation Shielding Tray

FDA UDI

Class I (US FDA UDI)

by GT Medical Technologies

Identity

Trade Name
GammaTile Radiation Shielding Tray FDA UDI
Generic Name
Radiation shielding container, transport/transfer FDA UDI
Model / Reference
GT-002 FDA UDI

Identifiers

Primary DI / UDI-DI
00860000064514 FDA UDI
FDA Product Code
KPY FDA UDI
GMDN Term
Radiation shielding container, transport/transfer FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.6500 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Radiation shielding container, transport/transfer

GammaTile Radiation Shielding Tray by GT Medical Technologies — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiation shielding container, transport/transfer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GT Medical Technologies

Sources (1)

  • FDA UDI ba46b35d-266e-472c-87bf-4c0e59a3aede 32 fields · synced Sep 18, 2026