FDA UDI
In Commercial Distribution
🇺🇸 United States
Tissue Seal
DI: 00860000589024
·
Model: TS1050071-FP
·
TISSUE SEAL L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Tissue Seal
- Primary DI
- 00860000589024
- Version / Model
- TS1050071-FP
- Catalog Number
- TS1050071-FP
- Company Name
- TISSUE SEAL L.L.C.
- Labeler DUNS
- 805666588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-01
- Public Version
- 1
- Public Version Date
- 2019-12-09
- Public Version Status
- New
- Public Device Record Key
- 90b20fcf-2ad5-4346-bbb1-3e7d6c4c877c
Device Description
Topical Skin Adhesive Clear
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 | 10860000589021 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00860000589024 | GS1 |
Customer Contacts
- Phone
- 877-754-6458
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111959 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 0.5 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 22 Degrees Celsius