FDA UDI
In Commercial Distribution
🇺🇸 United States
BoneMedik-DM 1.0~2.0mm, 0.25g
DI: 08806387897187
·
Model: 9718
·
Meta Biomed Co., Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BoneMedik-DM 1.0~2.0mm, 0.25g
- Primary DI
- 08806387897187
- Version / Model
- 9718
- Company Name
- Meta Biomed Co., Ltd.
- Labeler DUNS
- 688322841
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 2de0bacd-8ff8-4fee-bb53-8ff1685a00d3
Device Description
BoneMedik-DM is a coralline hydroxyapatite and a more active tricalcium phosphate bone grafting material for dental and craniofacial usage. It is comprised of 60% silicon substituted hydroxyapatite and 40% [3-tricalcium phosphate.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | Dental | 872.3930 | 2 |
| NPM | Bone Grafting Material, Animal Source | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47698 | Tungsten-weighted oesophageal dilator | A surgical instrument in the form of a strong-walled rubber tube filled with tungsten (W) designed to dilate the oesophagus using a single dilator, or dilators of sequentially increasing sizes. The device is internally weighted with the tungsten for gravity assistance [and to avoid the potential hazards of manipulation with mercury (Hg)] when blindly inserted into the oesophagus of an upright patient; it may have a round or fine tip increasing to full diameter over several centimeters from the tip. The device is commonly referred to as a Maloney or Hurst dilator and is intended to treat cardiospasm, oesophagitis, and stenosis. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08806387897187 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080772 | 000 |