FDA UDI
Not in Commercial Distribution
🇺🇸 United States
COVAORTHO-NERVE
DI: 03760193182033
·
Model: MCG 13 34 V
·
DILON TECHNOLOGIES FRANCE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COVAORTHO-NERVE
- Primary DI
- 03760193182033
- Version / Model
- MCG 13 34 V
- Catalog Number
- COVO34
- Company Name
- DILON TECHNOLOGIES FRANCE
- Labeler DUNS
- 279346203
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-02-25
- Public Version
- 8
- Public Version Date
- 2023-10-04
- Public Version Status
- Update
- Public Device Record Key
- 8acde927-93e7-42af-8fd8-5977120c386f
- Distribution End Date
- 2019-05-21
Device Description
Collagen Guided Healing Membrane
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 |
|---|---|---|---|---|
| JXI | Cuff, Nerve | Neurology | 882.5275 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34212 | Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated | A bioabsorbable, surgically-implanted device intended to prevent the abnormal fibrous union (adhesion) between one internal body part/tissue and another following a surgical procedure; neither antimicrobials nor pharmaceuticals are included. It may be supplied as a barrier membrane, hydratable gel, or fluid dressing and is made of appropriate material (e.g., collagen- or hyaluronic acid-based) to reduce adhesion between adjacent anatomical structures. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03760193182033 | GS1 |
Customer Contacts
- Phone
- +3348657610
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103081 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 40 | Millimeter | |
| Width | 30 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Dry place away from humidity