FDA UDI
In Commercial Distribution
🇺🇸 United States
CIV-Clear™ Transducer Cover
DI: 10841436120262
·
Model: 610-2361
·
CIVCO MEDICAL INSTRUMENTS CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CIV-Clear™ Transducer Cover
- Primary DI
- 10841436120262
- Version / Model
- 610-2361
- Catalog Number
- 610-2361, 610-2361-5
- Company Name
- CIVCO MEDICAL INSTRUMENTS CO., INC.
- Labeler DUNS
- 134614411
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-20
- Public Version
- 2
- Public Version Date
- 2022-10-28
- Public Version Status
- Update
- Public Device Record Key
- 4bb7a4f6-7ae3-47ac-a71d-eb795e2bb7e7
Device Description
Sterile (14x61cm) flat-folded cover
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITX | Transducer, ultrasonic, diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44713 | Body-surface ultrasound imaging transducer cover | A device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00841436120265 | GS1 | 24 | In Commercial Distribution | ||
| Primary | 10841436120262 | GS1 | ||||
| Package | 00841436122917 | GS1 | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(319)248-6502
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211270 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Sunlight