FDA UDI
In Commercial Distribution
🇺🇸 United States
RegenaVate™ DBM Fill RT, 1cc
DI: 00854095006757
·
Model: ZR0101
·
Rti Surgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RegenaVate™ DBM Fill RT, 1cc
- Primary DI
- 00854095006757
- Version / Model
- ZR0101
- Catalog Number
- 013010Z
- Company Name
- Rti Surgical, Inc.
- Labeler DUNS
- 117560455
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-11-06
- Public Version
- 7
- Public Version Date
- 2023-10-19
- Public Version Status
- Update
- Public Device Record Key
- 3d716368-2764-4783-9baa-33cd40e9f913
Device Description
DBM Fill RT, 1cc
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NUN | BONE GRAFTING MATERIAL, HUMAN SOURCE | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47257 | Bone matrix implant, human-derived | An sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The device is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for the stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is available in the form of powder, crushed granules, putty, chips, or a gel that can be injected through a syringe. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854095006757 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080418 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 37 Degrees Celsius