FDA UDI
In Commercial Distribution
🇺🇸 United States
Dynamic Tissue Systems™
DI: 00620974001799
·
Model: DCNE-02
·
Southmedic Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
28
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Basic Information
- Brand Name
- Dynamic Tissue Systems™
- Primary DI
- 00620974001799
- Version / Model
- DCNE-02
- Catalog Number
- DCNE-02
- Company Name
- Southmedic Incorporated
- Labeler DUNS
- 246848147
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 28
- Record Status
- Published
- Publish Date
- 2020-12-18
- Public Version
- 1
- Public Version Date
- 2020-12-28
- Public Version Status
- New
- Public Device Record Key
- 34c5f477-173e-4a43-91f7-cd1e13218fd1
Device Description
DynaCleft Nasal Elevation System
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
- Yes
- 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 |
|---|---|---|---|---|
| MZR | TOPICAL APPROXIMATION SYSTEM | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32207 | Skin-closure adhesive strip | A small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10620974001796 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00620974001799 | GS1 | ||||
| Unit of Use | 20620974001793 | GS1 |
Customer Contacts
- Phone
- +1(705)726-9383
- [email protected]