FDA UDI
In Commercial Distribution
🇺🇸 United States
EZ Fan Funnel 2
DI: 08800071700050
·
Model: REF_02KR
·
KimsMed Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EZ Fan Funnel 2
- Primary DI
- 08800071700050
- Version / Model
- REF_02KR
- Company Name
- KimsMed Co.,Ltd.
- Labeler DUNS
- 695898800
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-06
- Public Version
- 1
- Public Version Date
- 2023-02-14
- Public Version Status
- New
- Public Device Record Key
- 34fef023-1642-49ac-88ad-e1f78498de2d
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
- No
- 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 |
|---|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58219 | Breast implant delivery funnel, manual | A manually-operated device in the form of a cylindrical cone designed to assist with the delivery of a prefilled breast implant during implant insertion into a surgically-created breast pocket. It is a funnel-shaped device made of a pliable material (e.g., nylon) that may be coated to improve its lubricity. The breast implant is manually squeezed to and through the narrow distal end of the device to enable placement via a small incision (e.g., in the armpit region). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800071700050 | GS1 |
Customer Contacts
- Phone
- +827052085257
- [email protected]