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Astra Tee

FDA UDI

Class II (US FDA UDI)

by Civco Medical Instruments Co., Inc.

Identity

Trade Name
Astra Tee FDA UDI
Generic Name
Ultrasound imaging transducer washer-disinfector (chemical) FDA UDI
Device Name
ASTRA TEE Transesophageal Probe Reprocessor FDA UDI
Model / Reference
A9009-01 FDA UDI
Description
ASTRA TEE Transesophageal Probe Reprocessor FDA UDI

Identifiers

Catalog Number
610-1338 FDA UDI
Primary DI / UDI-DI
00841436111287 FDA UDI
510(k) Number
K150504 FDA UDI
FDA Product Code
ITX FDA UDI
GMDN Term
Ultrasound imaging transducer washer-disinfector (chemical) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 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

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Width — 12 Inch FDA UDI
Height — 48 Inch FDA UDI

Category: Ultrasound imaging transducer washer-disinfector (chemical)

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

Similar devices

Also classified as Ultrasound imaging transducer washer-disinfector (chemical).

Cleared under the same submission

K150504 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 d39b5617-6464-4648-86db-dc0aa159459a 37 fields · synced Jun 6, 2026