← Back to catalogue

BrachyGel Vaginal Hydrogel Packing System

FDA UDI

Class II (US FDA UDI)

by Medtec LLC

Identity

Trade Name
BrachyGel Vaginal Hydrogel Packing System FDA UDI
Generic Name
Vaginal brachytherapy system applicator, manual FDA UDI
Device Name
BrachyGel Vaginal Hydrogel Packing System (BVHPS) FDA UDI
Model / Reference
RT-5300 FDA UDI
Description
BrachyGel Vaginal Hydrogel Packing System (BVHPS) FDA UDI

Identifiers

Catalog Number
RT-5300 FDA UDI
Primary DI / UDI-DI
00841439114582 FDA UDI
510(k) Number
DEN220052 FDA UDI
FDA Product Code
QXR FDA UDI
GMDN Term
Vaginal brachytherapy system applicator, manual FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5735 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

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 Safe FDA UDI

Category: Vaginal brachytherapy system applicator, manual

BrachyGel Vaginal Hydrogel Packing System by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vaginal brachytherapy system applicator, manual.

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
Medtec LLC

Sources (1)

  • FDA UDI 2ec5fae5-d905-4dbb-9b25-ad1cd628959d 37 fields · synced May 30, 2026