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Best Medical International

FDA UDI

Class I (US FDA UDI)

by Best Medical International, Inc.

Identity

Trade Name
Best Medical International FDA UDI
Generic Name
Bladder brachytherapy system applicator, manual FDA UDI
Model / Reference
237-1 FDA UDI

Identifiers

Primary DI / UDI-DI
00841365109485 FDA UDI
510(k) Number
K910862 FDA UDI
FDA Product Code
IWJ FDA UDI
GMDN Term
Bladder 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

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Bladder brachytherapy system applicator, manual

Best Medical International by Best Medical International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bladder brachytherapy system applicator, manual.

Cleared under the same submission

K910862 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Best Medical International, Inc.

Sources (1)

  • FDA UDI 531614f7-c661-4234-9ad2-364aae1e085e 33 fields · synced Jun 9, 2026