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Kobold® Henschke-model Tandem and Ovoid Applicator Set (E)

FDA UDI

Class II (US FDA UDI)

by Kobold, Llc

Identity

Trade Name
Kobold® Henschke-model Tandem and Ovoid Applicator Set (E) FDA UDI
Generic Name
Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
Model / Reference
704-000 FDA UDI

Identifiers

Primary DI / UDI-DI
00815568020007 FDA UDI
FDA Product Code
JAQ FDA UDI
GMDN Term
Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5700 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

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
MRI Safety
MR Unsafe FDA UDI

Category: Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Kobold® Henschke-model Tandem and Ovoid Applicator Set (E) by Kobold, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cervical/intrauterine brachytherapy system applicator, remote-afterloading.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kobold, Llc

Sources (1)

  • FDA UDI c20492a6-0bb2-4cad-a509-c39499e198af 32 fields · synced May 31, 2026