| Primary Device ID | 20865082000133 | 
| NIH Device Record Key | 987aed3e-7eea-44f6-a48b-b1bd99dbffa4 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Scintillant | 
| Version Model Number | 2658-01-0004 | 
| 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 | true | 
| 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 | 
| Phone | 908-329-9123 | 
| contact@bihlermed.com | |
| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
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| Phone | 908-329-9123 | 
| contact@bihlermed.com | |
| Phone | 908-329-9123 | 
| contact@bihlermed.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 10865082000136 [Primary] | 
| GS1 | 20865082000133 [Package] Contains: 10865082000136 Package: Box [5 Units] In Commercial Distribution | 
| GAD | Retractor | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 5 | 
| Public Version Date | 2021-01-08 | 
| Device Publish Date | 2016-08-19 | 
| 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 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SCINTILLANT  77144633  3421624 Live/Registered | Engineered Medical Solutions Company LLC 2007-03-30 |