FDA UDI
In Commercial Distribution
🇺🇸 United States
PORT LOCATOR
DI: 07445161009487
·
Model: MFPL-001
·
Establishment Labs S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PORT LOCATOR
- Primary DI
- 07445161009487
- Version / Model
- MFPL-001
- Catalog Number
- MFPL-001
- Company Name
- Establishment Labs S.A.
- Labeler DUNS
- 853166098
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-08
- Public Version
- 1
- Public Version Date
- 2023-12-18
- Public Version Status
- New
- Public Device Record Key
- 3ecf8ec3-d4ee-45be-8634-7fdfc38a7863
Device Description
PORT LOCATOR Motiva Flora Port Locator
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LCJ | Tissue Expander And Accessories | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46583 | Tissue expander injection port locator | A small, hand-held, manually-operated, sterile device designed to assist with the location of the subcutaneous injection port of an implanted tissue expander prior to the insertion of a filling needle into the port in order to fill the tissue expander with, e.g., saline. It is moved over the surface of the skin at the point where the concealed injection site is situated and an indicator, e.g., a small magnet, reacts to the metal material of the port, indicating where it is located. Repetition of this locating process on several axes provides the exact location of the injection site. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07445161009487 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211676 | 000 |