← Back to catalogue

Localizer Instrument Cover Kit

FDA UDI

Class II (US FDA UDI)

by Protek Medical Products, Inc.

Identity

Trade Name
Localizer Instrument Cover Kit FDA UDI
Generic Name
Body-surface ultrasound imaging transducer cover FDA UDI
Model / Reference
1080 FDA UDI

Identifiers

Catalog Number
1080 FDA UDI
Primary DI / UDI-DI
00841912104413 FDA UDI
510(k) Number
K970885 FDA UDI
FDA Product Code
MMP FDA UDI
GMDN Term
Body-surface ultrasound imaging transducer cover FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 FDA UDI
Commercial Distribution
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

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

Yes

FDA UDI

Category: Body-surface ultrasound imaging transducer cover

Localizer Instrument Cover Kit by Protek Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Body-surface ultrasound imaging transducer cover.

Cleared under the same submission

K970885 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Protek Medical Products, Inc.

Sources (1)

  • FDA UDI 9d474974-343f-4c9b-bcb7-f3b41d7454f1 34 fields · synced May 30, 2026