T-Gen
GUDID 08800048502380
Absorbable collagen membrane
HYUNDAI BIOLAND Co., Ltd.
Collagen dental regeneration membrane| Primary Device ID | 08800048502380 |
| NIH Device Record Key | ad8ae9a3-e75b-4c3c-b6c9-bb9783d0aada |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T-Gen |
| Version Model Number | TG-5 |
| Company DUNS | 688235061 |
| Company Name | HYUNDAI BIOLAND Co., Ltd. |
| 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 |
Device Dimensions
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800048502380 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200623
FDA Product Code
| NPL | Barrier, Animal Source, Intraoral |
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 | 2023-04-26 |
| Device Publish Date | 2023-04-18 |
On-Brand Devices [T-Gen]
| 08800048502380 | Absorbable collagen membrane |
| 08800048502373 | Absorbable collagen membrane |
| 08800048502366 | Absorbable collagen membrane |
| 08800048502359 | Absorbable collagen membrane |
| 08800048502342 | Absorbable collagen membrane |
Trademark Results [T-Gen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 T-GEN 85481144 4175553 Live/Registered |
Unimed International Inc. 2011-11-27 |
 T-GEN 76338305 not registered Dead/Abandoned |
HERBALIFE INTERNATIONAL, INC. 2001-11-16 |
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