FDA UDI
In Commercial Distribution
🇺🇸 United States
derma+flex QS
DI: 00854137001177
·
Model: QS70806
·
CHEMENCE MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- derma+flex QS
- Primary DI
- 00854137001177
- Version / Model
- QS70806
- Catalog Number
- QS70806
- Company Name
- CHEMENCE MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 079163089
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2022-05-18
- Public Version Status
- Update
- Public Device Record Key
- e24b952d-2102-4947-95c9-7faed11257ba
Device Description
Tissue Adhesive with Dauber/Nozzle AND derma+flex QS SourceMark, 0.7g product code M1201 and M1201-01
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 |
|---|---|---|---|---|---|---|
| Primary | 00854137001177 | GS1 | ||||
| Package | 10854137001174 | GS1 | Box | 6 | In Commercial Distribution | |
| Package | 20854137001171 | GS1 | Case | 6 | In Commercial Distribution | |
| Package | 30854137001178 | GS1 | Box | 6 | In Commercial Distribution | |
| Package | 40854137001175 | GS1 | Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 844-633-6583
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101276 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 86 Degrees Fahrenheit