Foundation 27-500-100
GUDID 20386040015247
Collagen-Based Bone Filling Augmentation Material
Gc America Inc.
Dental bone matrix implant, animal-derived| Primary Device ID | 20386040015247 |
| NIH Device Record Key | b648580b-e530-433b-8b3e-c86071ccf0da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Foundation |
| Version Model Number | 27-500-100 |
| Catalog Number | 27-500-100 |
| Company DUNS | 005473608 |
| Company Name | Gc America Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00386040015243 [Primary] |
| GS1 | 20386040015247 [Package] Contains: 00386040015243 Package: Box [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111087
FDA Product Code
| LYC | Bone grafting material, synthetic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-20 |
| Device Publish Date | 2024-03-12 |
On-Brand Devices [Foundation]
| 20386040015254 | Collagen-Based Bone Filling Augmentation Material |
| 20386040015247 | Collagen-Based Bone Filling Augmentation Material |
Trademark Results [Foundation]
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