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Esaote Needle Guide Only

FDA UDI

Class II (US FDA UDI)

by Civco Medical Instruments Co., Inc.

Identity

Trade Name
Esaote Needle Guide Only FDA UDI
Generic Name
Needle guide, reusable FDA UDI
Device Name
Reusable non-sterile general purpose needle guide for use with Esaote C1-8 transducers FDA UDI
Model / Reference
639-058 FDA UDI
Description
Reusable non-sterile general purpose needle guide for use with Esaote C1-8 transducers FDA UDI

Identifiers

Catalog Number
639-058 FDA UDI
Primary DI / UDI-DI
00841436111485 FDA UDI
510(k) Number
K093713 FDA UDI
FDA Product Code
ITX FDA UDI
GMDN Term
Needle guide, reusable 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

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
Length — 3.9 Inch FDA UDI
Width — 1.7 Inch FDA UDI

Category: Needle guide, reusable

Esaote Needle Guide Only by Civco Medical Instruments Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Needle guide, reusable.

Cleared under the same submission

K093713 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 66432795-abfa-4e55-875b-518939422577 38 fields · synced Jun 8, 2026