FDA UDI
In Commercial Distribution
🇺🇸 United States
Creos Xenogain Collagen
DI: 08809186540834
·
Model: N1410
·
Nibec Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Creos Xenogain Collagen
- Primary DI
- 08809186540834
- Version / Model
- N1410
- Company Name
- Nibec Co., Ltd.
- Labeler DUNS
- 687796909
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c6a274a0-a63b-4395-8387-da0edb66ac4e
Device Description
Creos Xenogain Collagen is a combination of purified cancellous bone mineral granules (Creos Xenogain) and 10% collagen in a block form in a blister and cylindrical form in a syringe and blister. It is sterilized by γ- irradiation.
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 | 08809186540834 | GS1 |
Customer Contacts
- Phone
- +827050068814
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142040 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | .25 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius