FDA UDI
In Commercial Distribution
🇺🇸 United States
EpiGuide® Bioresorbable Barrier Matrix
DI: 00812337027144
·
Model: 50600-03
·
DSM BIOMEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EpiGuide® Bioresorbable Barrier Matrix
- Primary DI
- 00812337027144
- Version / Model
- 50600-03
- Catalog Number
- 50600-03
- Company Name
- DSM BIOMEDICAL, INC.
- Labeler DUNS
- 131107757
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-20
- Public Version
- 2
- Public Version Date
- 2023-06-19
- Public Version Status
- Update
- Public Device Record Key
- 481fd243-7f76-4a31-b5a8-48d174326c72
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58503 | Pliable-polymer dental regeneration membrane, bioabsorbable, tacked | A sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. It is a synthetic polymer material that is held in place with bioabsorbable tacks fixed into the jawbone; it is applied between soft tissue and bone during periodontal flap surgery and other guided bone regeneration (GBR) and guided tissue regeneration (GTR) surgical procedures. The tacks and a plasticizer used to temporarily soften the membrane may be included. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812337027144 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K940643 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 30 | Millimeter | |
| Width | 18 | Millimeter |