FDA UDI
In Commercial Distribution
🇺🇸 United States
Cytoflex Resorb
DI: D767C0301010
·
Model: 30x40mm
·
UNICARE BIOMEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cytoflex Resorb
- Primary DI
- D767C0301010
- Version / Model
- 30x40mm
- Catalog Number
- C03-0101
- Company Name
- UNICARE BIOMEDICAL INC.
- Labeler DUNS
- 038023573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 4
- Public Version Date
- 2021-07-27
- Public Version Status
- Update
- Public Device Record Key
- 00f1d4ac-18b0-4640-beb7-f4e1c90d9186
Device Description
Cytoflex® Resorb is a synthetic, microporous resorbable barrier membrane. Cytoflex® Resorb membranes are designed to enhance the adhesion of host cells, and at the same time provide a favorable environment for neo-vascularization and repopulation of bone cells to regenerate osseous tissue. The flexible barrier membranes are easily adaptable to tissue contours, yet offer sufficient duration to protect the bony defect from the intrusion of bacteria and soft tissue. Composed of synthetic polylactide and polyglycolide copolymers, Cytoflex® Resorb barriers are resorbable and do not require a second retrieval procedure.
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 |
|---|---|---|---|---|
| NPK | Barrier, Synthetic, Intraoral | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58502 | Pliable-polymer dental regeneration membrane, bioabsorbable, ligated | 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 pliable synthetic polymer material that is held in place between soft tissue and bone [e.g., with ligatures, sutures, or pins (may be attached/included)] and applied during periodontal flap surgery and other guided bone regeneration (GBR) and guided tissue regeneration (GTR) surgical procedures. A plasticizer to 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 | D767C0301010 | HIBCC |
Customer Contacts
- Phone
- 949-305-9600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090083 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 65 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry, well ventilated environment. Keep out of sunlight.