FDA UDI
In Commercial Distribution
🇺🇸 United States
Straumann Regenomer
DI: 08809186542050
·
Model: RSB1-S
·
Nibec Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Straumann Regenomer
- Primary DI
- 08809186542050
- Version / Model
- RSB1-S
- Company Name
- Nibec Co., Ltd.
- Labeler DUNS
- 687796909
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-17
- Public Version
- 1
- Public Version Date
- 2018-09-17
- Public Version Status
- New
- Public Device Record Key
- b4b3ba53-8ded-47f7-84fb-fb96f647ab00
Device Description
Straumann® Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Straumann® Regenomer® is manufactured in three types,Straumann® Regenomer® Syringe (sheet shape in syringe and blister), Straumann® Regenomer® Plug (bullet shape in blister), and Straumann® Regenomer® Block (block shape in blister). Straumann® Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
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
- Yes
- 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 |
|---|---|---|---|---|
| NPM | Bone Grafting Material, Animal Source | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47968 | Dental bone matrix implant, animal-derived | A sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809186542050 | GS1 |
Customer Contacts
- Phone
- +827050068814
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150079 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6mm X 5mm X 7mm |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius