FDA UDI
Not in Commercial Distribution
🇺🇸 United States
LiquiBand Flex
DI: 05036912000697
·
Model: LBF001
·
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- LiquiBand Flex
- Primary DI
- 05036912000697
- Version / Model
- LBF001
- Company Name
- ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED
- Labeler DUNS
- 236059171
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-06
- Public Version
- 5
- Public Version Date
- 2018-12-28
- Public Version Status
- Update
- Public Device Record Key
- 5870abb4-b33d-4b17-b267-5b9c509c4eb1
- Distribution End Date
- 2018-12-28
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
- 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 |
|---|---|---|---|---|
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | General, Plastic Surgery | 878.4010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34164 | Skin-approximation adhesive | A sterile biodegradable glue made of synthetic polymer (e.g., cyanoacrylate) intended for topical closure of surgical incisions and simple traumatic lacerations that have easily-approximated skin edges; it is not intended for internal surgical applications. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05036912000925 | GS1 | Shipper Carton | 6 | Not in Commercial Distribution | 2018-12-28 |
| Package | 05036912000529 | GS1 | Carton | 10 | Not in Commercial Distribution | 2018-12-28 |
| Primary | 05036912000697 | GS1 |
Customer Contacts
- Phone
- +448444125754
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102076 | 000 |