FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TIGER GUARD PLUS
DI: 08800071700500
·
Model: REF_02KR
·
Kims Med Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- TIGER GUARD PLUS
- Primary DI
- 08800071700500
- Version / Model
- REF_02KR
- Company Name
- Kims Med Co.,Ltd.
- Labeler DUNS
- 963342901
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-28
- Public Version
- 3
- Public Version Date
- 2026-02-27
- Public Version Status
- Update
- Public Device Record Key
- e19edf18-8479-40f7-8768-973b1cb9dbf0
- Distribution End Date
- 2026-02-27
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58219 | Breast/gluteal 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 and/or gluteal implant during implant insertion into a surgically-created pocket. Also referred to as a Keller funnel, it is a funnel-shaped device made of a pliable material (e.g., nylon) that may be coated to improve its lubricity. The 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 |
|---|---|---|---|---|---|---|
| Package | 08800071700517 | GS1 | 5 | Not in Commercial Distribution | 2026-02-27 | |
| Primary | 08800071700500 | GS1 |
Customer Contacts
- Phone
- +827052085257
- [email protected]