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CIV-Clear™ Transducer Cover

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 610-2367Ref 610-2363Ref 610-2365Ref 610-2364Ref 610-2366Ref 610-2362

by Civco Medical Instruments Co., Inc.

Identity

Trade Name
CIV-Clear™ Transducer Cover EUDAMEDFDA UDI
Generic Name
Body-surface ultrasound imaging transducer cover FDA UDI
Intraoperative ultrasound imaging transducer cover FDA UDI
Device Name
General Purpose and Intraoperative Covers (CIV-Clear sterile) EUDAMED
Sterile (14x91.5cm) telescopically-folded cover FDA UDI
Sterile (14x122cm) telescopically-folded cover FDA UDI
Sterile (8.9x91.5cm) telescopically-folded cover FDA UDI
Sterile (10.2x122cm) telescopically-folded cover (no gel) FDA UDI
Sterile (10.2x122cm) telescopically-folded cover FDA UDI
Sterile (14x244cm) telescopically-folded cover FDA UDI
Model / Reference
610-2362 EUDAMEDFDA UDI
610-2363 EUDAMEDFDA UDI
610-2364 EUDAMEDFDA UDI
610-2367 EUDAMEDFDA UDI
610-2365 EUDAMEDFDA UDI
610-2366 EUDAMEDFDA UDI
Description
Sterile (14x91.5cm) telescopically-folded cover FDA UDI
Sterile (14x122cm) telescopically-folded cover FDA UDI
Sterile (8.9x91.5cm) telescopically-folded cover FDA UDI
Sterile (10.2x122cm) telescopically-folded cover (no gel) FDA UDI
Sterile (10.2x122cm) telescopically-folded cover FDA UDI
Sterile (14x244cm) telescopically-folded cover FDA UDI

Identifiers

Catalog Number
610-2362, 610-2362-5 FDA UDI
610-2363, 610-2363-5 FDA UDI
610-2364, 610-2364-5 FDA UDI
610-2367 FDA UDI
610-2365, 610-2365-5 FDA UDI
610-2366, 610-2366-5 FDA UDI
Primary DI / UDI-DI
10841436120279 EUDAMEDFDA UDI
10841436120286 EUDAMEDFDA UDI
10841436120293 EUDAMEDFDA UDI
10841436120323 EUDAMEDFDA UDI
10841436120309 EUDAMEDFDA UDI
10841436120316 EUDAMEDFDA UDI
Basic UDI-DI
0841436101TD201A9P2 EUDAMED
510(k) Number
K211270 FDA UDI
FDA Product Code
ITX FDA UDI
EMDN Code
T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
GMDN Term
Body-surface ultrasound imaging transducer cover FDA UDI
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

Category: Body-surface ultrasound imaging transducer cover

CIV-Clear™ 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 Body-surface ultrasound imaging transducer cover.

Cleared under the same submission

K211270 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 (12)

  • FDA UDI 6a5f2048-8bb9-4e0e-8c2c-1371dbdcde8e 37 fields · synced Oct 8, 2026
  • FDA UDI 538f166d-3d98-4c31-bda8-a12bd71f1815 37 fields · synced May 29, 2026
  • FDA UDI 28b1e5a2-3469-4faf-9698-f7d8dd32f432 37 fields · synced May 30, 2026
  • FDA UDI fafcbeb9-102b-4f9e-b057-58abababd66a 37 fields · synced May 30, 2026
  • FDA UDI d3656fde-aca4-4be6-8b23-5dc4b3f828b9 37 fields · synced May 30, 2026
  • FDA UDI 673c14e1-0f07-4201-b807-026df406f36c 37 fields · synced May 30, 2026
  • EUDAMED 674569aa-fba1-42c3-8f5e-f33c1916da74 61 fields · synced Jul 19, 2026
  • EUDAMED 4a9a156c-ffa7-460a-90b9-599f8a58bc3a 61 fields · synced Jul 20, 2026
  • EUDAMED eb5ea19b-ad39-4f19-8b1b-9f2d166d9eae 61 fields · synced Jul 28, 2026
  • EUDAMED 3ad82eaf-fee3-4ad8-856e-13fd70500c7f 61 fields · synced Jul 30, 2026
  • EUDAMED 245a7d2d-3e8d-4ede-9bfc-0c610a32a204 61 fields · synced Sep 18, 2026
  • EUDAMED ab6b11d0-0f93-48fa-b7d2-0bde8d8deb91 61 fields · synced Oct 8, 2026