FDA UDI
In Commercial Distribution
🇺🇸 United States
Needle Guide
DI: 00841436100663
·
Model: 04392143
·
CIVCO MEDICAL INSTRUMENTS CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Needle Guide
- Primary DI
- 00841436100663
- Version / Model
- 04392143
- Catalog Number
- 04392143
- 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
- 2017-08-22
- Public Version
- 9
- Public Version Date
- 2022-06-17
- Public Version Status
- Update
- Public Device Record Key
- 7fefcc32-d44a-4a41-8c55-06f4db5158a2
Device Description
Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with Siemens 6.5EV13, 6.5EV13+, 6.5EV13S AND EV9-4 (on SONOLINE G20, G50, G60 S systems) transducers
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYO | System, imaging, pulsed echo, ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60734 | Needle guide, reusable | A non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, guides for ultrasound-guided percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a reusable device intended to be sterilized/disinfected prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841436100663 | GS1 | ||||
| Direct Marking | 20841436115074 | GS1 |
Customer Contacts
- Phone
- +1(319)248-6502
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K875240 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 7.4 | Inch | |
| Width | 1.2 | Inch |