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Tracking Bracket

FDA UDI

Class II (US FDA UDI)

by Civco Medical Instruments Co., Inc.

Identity

Trade Name
Tracking Bracket FDA UDI
Generic Name
Ultrasound imaging system tracking positioner, single-use FDA UDI
Device Name
Sterile tracking bracket for use with Hologic Celero biopsy instrument FDA UDI
Model / Reference
653-001 FDA UDI
Description
Sterile tracking bracket for use with Hologic Celero biopsy instrument FDA UDI

Identifiers

Catalog Number
653-001 FDA UDI
Primary DI / UDI-DI
10841436106044 FDA UDI
510(k) Number
K092619 FDA UDI
FDA Product Code
IYO FDA UDI
GMDN Term
Ultrasound imaging system tracking positioner, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Width — 1.57 Inch FDA UDI
Length — 1.89 Inch FDA UDI

Tracking Bracket by Civco Medical Instruments Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K092619 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 d478d539-2685-4f46-98ba-073a381411ff 39 fields · synced Jun 8, 2026