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Surgi-Boot Transducer Cover

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 610-797Ref UA0075

by Civco Medical Instruments Co., Inc.

Identity

Trade Name
Surgi-Boot Transducer Cover EUDAMEDFDA UDI
Generic Name
Intraoperative ultrasound imaging transducer cover FDA UDI
Device Name
General Purpose and Intraoperative Covers (Surgi-tip sterile) EUDAMED
Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached form-fitting NeoGuard™ tip FDA UDI
Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached form-fitting NeoGuard™ tip for use with BK Medical 8809 transducers FDA UDI
Model / Reference
UA0075 EUDAMEDFDA UDI
610-797 EUDAMED
610-797, 610-797-5 FDA UDI
Description
Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached form-fitting NeoGuard™ tip FDA UDI
Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached form-fitting NeoGuard™ tip for use with BK Medical 8809 transducers FDA UDI

Identifiers

Catalog Number
610-797, 610-797-5 FDA UDI
UA0075 FDA UDI
Primary DI / UDI-DI
10841436104163 EUDAMEDFDA UDI
10841436110379 EUDAMEDFDA UDI
Basic UDI-DI
0841436101TD201A12RM EUDAMED
510(k) Number
K013721 FDA UDI
FDA Product Code
ITX FDA UDI
EMDN Code
T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
GMDN Term
Intraoperative ultrasound imaging transducer cover FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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
Length — 96 Inch FDA UDI
Width — 6 Inch FDA UDI
Width — 15.2 Inch FDA UDI
Length — 244 Centimeter FDA UDI

Category: Intraoperative ultrasound imaging transducer cover

Surgi-Boot Transducer Cover by Civco Medical Instruments Co., Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Intraoperative ultrasound imaging transducer cover.

Cleared under the same submission

K013721 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Civco Medical Instruments Co., Inc.

Sources (4)

  • FDA UDI 52edc161-9718-4399-9742-3509f378073e 38 fields · synced Oct 6, 2026
  • FDA UDI 971add9c-e554-4a51-a7d4-833ecac8023b 38 fields · synced May 30, 2026
  • EUDAMED bf413768-367d-42f7-b057-c495b29bb267 61 fields · synced Jul 10, 2026
  • EUDAMED 633647f4-26f9-4280-b612-44f0bb237c38 61 fields · synced Sep 17, 2026