← Back to catalogue

D&K Technologies

FDA UDI

Class I (US FDA UDI)

by FUJIFILM Healthcare Americas Corporation

Identity

Trade Name
D&K Technologies FDA UDI
Generic Name
Prostate brachytherapy system applicator, manual FDA UDI
Device Name
System Arm, Stabilizer, Stepper & Stand FDA UDI
Model / Reference
DK-ARM-KIT FDA UDI
Description
System Arm, Stabilizer, Stepper & Stand FDA UDI

Identifiers

Primary DI / UDI-DI
00869047000455 FDA UDI
FDA Product Code
IWJ FDA UDI
GMDN Term
Prostate brachytherapy system applicator, manual FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.5650 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Prostate brachytherapy system applicator, manual

D&K Technologies by FUJIFILM Healthcare Americas Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Prostate 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
FUJIFILM Healthcare Americas Corporation

Sources (1)

  • FDA UDI 6c6fa375-668e-4579-9f1f-f8a0ecf43ae5 33 fields · synced Jun 8, 2026