FDA UDI
In Commercial Distribution
🇺🇸 United States
Reusable guide
DI: 03665134000059
·
Model: GPK490-5
·
KOELIS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Reusable guide
- Primary DI
- 03665134000059
- Version / Model
- GPK490-5
- 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
- 5
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- f4c7db27-f955-4752-b60e-83725d80ba81
Device Description
The device concerned is a metallic guide designed to be plugged on an endocavity ultrasound probe, to guide a linear instrument through transrectal access. Sold *5
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 |
|---|---|---|---|---|
| 45018 | Needle guide, single-use | A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03665134000059 | GS1 | ||||
| Unit of Use | 03665134000042 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141334 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 161.5 | Millimeter | |
| Width | 40 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Rigid container, padded. Store them in maximum hygienic conditions at room temperature