FDA UDI
In Commercial Distribution
🇺🇸 United States
NeoGuard™
DI: 00841436104197
·
Model: 610-836-5
·
CIVCO MEDICAL INSTRUMENTS CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- NeoGuard™
- Primary DI
- 00841436104197
- Version / Model
- 610-836-5
- Catalog Number
- 610-836-5
- Company Name
- CIVCO MEDICAL INSTRUMENTS CO., INC.
- Labeler DUNS
- 134614411
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2017-08-22
- Public Version
- 6
- Public Version Date
- 2022-12-06
- Public Version Status
- Update
- Public Device Record Key
- d95366ff-d204-4338-a5dc-3776a875fef6
Device Description
Non-sterile (2.6 x 30cm) 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
- No
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITX | Transducer, ultrasonic, diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60608 | Body-orifice ultrasound imaging transducer cover, basic | A sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841436104197 | GS1 | ||||
| Unit of Use | 80841436104193 | GS1 |
Customer Contacts
- Phone
- +1(319)248-6502
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013721 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 17.72 | Inch | |
| Length | 3.15 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 52 – 85 Degrees Fahrenheit