FDA UDI
In Commercial Distribution
🇺🇸 United States
InnoFine
DI: 06971554725203
·
Model: DE-020
·
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- InnoFine
- Primary DI
- 06971554725203
- Version / Model
- DE-020
- Catalog Number
- DE-020
- Company Name
- JingFang Precision Medical Device(Shenzhen) Co., Ltd.
- Labeler DUNS
- 544571975
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-27
- Public Version
- 5
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- e46798c1-e117-433b-a3ff-5a6535fa5237
Device Description
Disposable Needle Guides for use with SuperSonic SE12-3; Siemens EC-10C5, EC9-4(ACUSON X500;SONOLINE G20, G50, G60S), EV9-4(ACUSON X500); ECM E610A Ultrasound Transducers
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OIJ | Biopsy Needle Guide Kit | Radiology | 892.1560 | 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 |
|---|---|---|---|---|---|---|
| Package | 16971554725200 | GS1 | 24 | In Commercial Distribution | ||
| Primary | 06971554725203 | GS1 |
Customer Contacts
- Phone
- +8675527597952
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 86 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Sunlight