FDA UDI
In Commercial Distribution
🇺🇸 United States
LIQUIFIX FIX8
DI: 05036912001410
·
Model: 72014032
·
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- LIQUIFIX FIX8
- Primary DI
- 05036912001410
- Version / Model
- 72014032
- Company Name
- ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED
- Labeler DUNS
- 236059171
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-23
- Public Version
- 1
- Public Version Date
- 2023-07-03
- Public Version Status
- New
- Public Device Record Key
- 9b1a83cf-da59-41ce-a089-009aeaaeced4
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| PLJ | Tissue Adhesive Internal Use | General, Plastic Surgery | 878.4010 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58777 | Surgical internal adhesive/sealant, synthetic polymer | A biodegradable synthetic polymer material [e.g., cyanoacrylate, poly glycerol sebacate arylate (PGSA)] intended to be used for internal surgical applications to bond a wide range of tissue types (e.g., bowel, liver, lung, vascular, urological) and might in addition be intended to achieve haemostasis through tissue sealing. It is applied using a disposable applicator (which may be included), and is intended to be fast-setting (self- or light-induced) to form a thin elastic film. After application, this device cannot be reused. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05036912001427 | GS1 | Unit Carton | 1 | In Commercial Distribution | |
| Primary | 05036912001410 | GS1 | ||||
| Package | 05036912001434 | GS1 | Shipper | 6 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P220024 | 000 |