FDA UDI
In Commercial Distribution
🇺🇸 United States
Medichoice
DI: 10885632077470
·
Model: LBXXS1MC
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Medichoice
- Primary DI
- 10885632077470
- Version / Model
- LBXXS1MC
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-11
- Public Version
- 1
- Public Version Date
- 2019-03-19
- Public Version Status
- New
- Public Device Record Key
- 13e12457-1cc9-48a1-9426-5ec1c0df9907
Device Description
LiquiBand Exceed XS/Topical Skin Adhesive/0.4g per EA/6 EA per box/6 box per case
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
- Yes
- 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 | 30885632077474 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 10885632077470 | GS1 | ||||
| Package | 20885632077477 | GS1 | 6 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151182 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Away from moisture, direct heat and direct light
- Type
- Special Storage Condition, Specify
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 77 Degrees Fahrenheit