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Multi-Purpose Workstation™ Stabilizer

FDA UDI

Class II (US FDA UDI)

by Civco Medical Instruments Co., Inc.

Identity

Trade Name
Multi-Purpose Workstation™ Stabilizer FDA UDI
Generic Name
Prostate brachytherapy system applicator, manual FDA UDI
Device Name
Floor Mount FDA UDI
Model / Reference
610-974 FDA UDI
Description
Floor Mount FDA UDI

Identifiers

Catalog Number
610-974 FDA UDI
Primary DI / UDI-DI
00841436104647 FDA UDI
510(k) Number
K131161 FDA UDI
FDA Product Code
ITX FDA UDI
IWJ FDA UDI
JAQ FDA UDI
GMDN Term
Prostate brachytherapy system applicator, manual FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
892.5650 FDA UDI
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

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 27.2 Inch FDA UDI
Length — 27.6 Inch FDA UDI

Category: Prostate brachytherapy system applicator, manual

Multi-Purpose Workstation™ Stabilizer by Civco Medical Instruments Co., Inc. — 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

K131161 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Civco Medical Instruments Co., Inc.

Sources (1)

  • FDA UDI f35a7360-4f23-4075-b11e-2a6dec6a806c 37 fields · synced Jun 8, 2026