FDA UDI
In Commercial Distribution
🇺🇸 United States
transP - perine full grid 14G
DI: 03665134000264
·
Model: KRNG.EL4.14-5
·
KOELIS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- transP - perine full grid 14G
- Primary DI
- 03665134000264
- Version / Model
- KRNG.EL4.14-5
- Company Name
- KOELIS
- Labeler DUNS
- 290318455
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2020-07-17
- Public Version
- 2
- Public Version Date
- 2022-06-17
- Public Version Status
- Update
- Public Device Record Key
- 6e8d0ac0-e629-49d9-99b1-85b7e4911298
Device Description
The guides from PERINE range are intended to guide a needle during ultrasound-guided intervention. PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane. The guides are reusable medical devices.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|---|---|
| Unit of Use | 03665134000134 | GS1 | ||||
| Primary | 03665134000264 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171040 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Guidewire Diameter | 1.02 | Millimeter |