SurgiMac
GUDID D10512178BX4
Mac Bite Registration Material - 50ml, 4/BX
Surgimac LLC
Silicone dental impression material| Primary Device ID | D10512178BX4 |
| NIH Device Record Key | 82d558b3-87c4-4361-b816-7e0a8501a44f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SurgiMac |
| Version Model Number | 12178-4 |
| Company DUNS | 060635048 |
| Company Name | Surgimac LLC |
| Device Count | 4 |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D10512178BX4 [Unit of Use] |
| HIBCC | D12178BX4 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221668
FDA Product Code
| ELW | Material, Impression |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-07 |
| Device Publish Date | 2024-12-30 |
On-Brand Devices [SurgiMac ]
Trademark Results [SurgiMac]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGIMAC 90034986 not registered Live/Pending |
Waseem, Umair 2020-07-03 |
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