FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Needle Guide Bracket
DI: 00841436107167
·
Model: 674-057-10
·
CIVCO MEDICAL INSTRUMENTS CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Needle Guide Bracket
- Primary DI
- 00841436107167
- Version / Model
- 674-057-10
- Catalog Number
- 674-057-10
- Company Name
- CIVCO MEDICAL INSTRUMENTS CO., INC.
- Labeler DUNS
- 134614411
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- 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
- 8e48882a-b628-41e0-98d9-b40f74fa8e6a
- Distribution End Date
- 2020-10-01
Device Description
Reusable non-sterile bracket for use with FUJIFILM SonoSite L25 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 |
|---|---|---|---|---|
| ITX | Transducer, ultrasonic, diagnostic | Radiology | 892.1570 | 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 | 00841436107167 | GS1 | ||||
| Unit of Use | 80841436107163 | GS1 | ||||
| Direct Marking | 20841436115333 | GS1 |
Customer Contacts
- Phone
- +1(319)248-6502
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093713 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 1.2 | Inch | |
| Length | 1.8 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 52 – 85 Degrees Fahrenheit