Identity
- Trade Name
- NeoGuard™ EUDAMEDFDA UDI
- Generic Name
- Body-orifice ultrasound imaging transducer cover, basic FDA UDI
- Device Name
- Intracavity Covers (Neoguard non-sterile) EUDAMEDNon-sterile (4 x 30cm) cover FDA UDI
- Model / Reference
- 610-838 EUDAMEDFDA UDI
- Description
- Non-sterile (4 x 30cm) cover FDA UDI
Identifiers
- Catalog Number
- 610-838 FDA UDI
- Primary DI / UDI-DI
- 00841436104210 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD201C6P2 EUDAMED
- Unit of Use DI
- 80841436104216 EUDAMED
- 510(k) Number
- K013721 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
- GMDN Term
- Body-orifice ultrasound imaging transducer cover, basic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Width — 4 Centimeter FDA UDILength — 30 Centimeter FDA UDI
Category: Body-orifice ultrasound imaging transducer cover, basic
NeoGuard™ by Civco Medical Instruments Co., Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Body-orifice ultrasound imaging transducer cover, basic.
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Cleared under the same submission
K013721 also covers:
- Laparoscopic Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Laparoscopic Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- NeoGuard Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- NeoGuard™ — CIVCO MEDICAL INSTRUMENTS CO., INC.
- NeoGuard™ — CIVCO MEDICAL INSTRUMENTS CO., INC.
- NeoGuard™ — CIVCO MEDICAL INSTRUMENTS CO., INC.
- NeoGuard™ — CIVCO MEDICAL INSTRUMENTS CO., INC.
- NeoGuard™ — CIVCO MEDICAL INSTRUMENTS CO., INC.
- NeoGuard™ — CIVCO MEDICAL INSTRUMENTS CO., INC.
- NeoGuard™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- NeoGuard™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- NeoGuard™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Civco Medical Instruments Co., Inc.
Sources (2)
- FDA UDI 885a1010-1ef8-4a1b-b820-e9a236e99037 38 fields · synced Jun 18, 2026
- EUDAMED 55a63e33-80dd-499e-bd3d-387661d9d2c4 61 fields · synced Jun 18, 2026