Scintillant

GUDID 20865082000119

Scintillant Surgical Light with Zip Strap

ENGINEERED MEDICAL SOLUTIONS COMPANY, L.L.C.

Operating room light

• Primary Device ID: 20865082000119
• NIH Device Record Key: dab4388c-8fe8-4964-a600-60055e083f9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scintillant
• Version Model Number: 2658-01-0001
• 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
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com
• Phone: 908-329-9123
• Email: contact@bihlermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10865082000112 [Primary]
GS1	20865082000119 [Package]; Contains: 10865082000112; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071180

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