Scintillant
GUDID 10865082000143
Scintillant Dual Bent Tip Surgical Light
ENGINEERED MEDICAL SOLUTIONS COMPANY, L.L.C.
Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light| Primary Device ID | 10865082000143 |
| NIH Device Record Key | a38677de-719f-496c-9287-6830f5237a36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Scintillant |
| Version Model Number | 2762-01-0003 |
| Company DUNS | 828549936 |
| Company Name | ENGINEERED MEDICAL SOLUTIONS COMPANY, L.L.C. |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com | |
| Phone | 908-329-9123 |
| contact@bihlermed.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10865082000143 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133425
FDA Product Code
| FTD | Lamp, Surgical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-01-08 |
| Device Publish Date | 2016-08-19 |
On-Brand Devices [Scintillant]
| 10865082000150 | Scintillant Dual Straight Tip Surgical Light |
| 10865082000143 | Scintillant Dual Bent Tip Surgical Light |
| 20865082000133 | Scintillant Surgical Light with Retractor |
| 20865082000126 | Scintillant Surgical Light with Suction |
| 20865082000119 | Scintillant Surgical Light with Zip Strap |
Trademark Results [Scintillant]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SCINTILLANT 77144633 3421624 Live/Registered |
Engineered Medical Solutions Company LLC 2007-03-30 |
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