SurgiMac 13-1257-H
GUDID D105SKU131257H13
Calcium-Hydroxide Placer, Hexa Series.
Surgimac LLC
Dental amalgam carrier| Primary Device ID | D105SKU131257H13 |
| NIH Device Record Key | 3e6fbf92-b66e-4dc9-aefd-165a2a0be114 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SurgiMac |
| Version Model Number | 13-1257-H |
| Catalog Number | 13-1257-H |
| Company DUNS | 060635048 |
| Company Name | Surgimac LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D105SKU131257H02 [Primary] |
| HIBCC | D105SKU131257H13 [Package] Contains: D105SKU131257H02 Package: Case [100 Units] In Commercial Distribution |
FDA Product Code
| EKI | Carrier, Amalgam, Operative |
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 | 2024-04-30 |
| Device Publish Date | 2024-04-22 |
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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