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Pl-7

FDA UDI

Class II (US FDA UDI)

by GT Medical Technologies

Identity

Trade Name
PL-7 FDA UDI
Generic Name
Prostate brachytherapy system applicator, manual FDA UDI
Model / Reference
PL-7 FDA UDI

Identifiers

Primary DI / UDI-DI
00860011485452 FDA UDI
510(k) Number
K202267 FDA UDI
FDA Product Code
KXK FDA UDI
GMDN Term
Prostate brachytherapy system applicator, manual FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5730 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Prostate brachytherapy system applicator, manual

Pl-7 by GT Medical Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Prostate brachytherapy system applicator, manual.

Cleared under the same submission

K202267 also covers:

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 21e6595b-f40a-4c74-bd74-ecdb2557bf4d 33 fields · synced Sep 18, 2026