Aspen® O.R. Camera Cover

GUDID 00840113219919

Intended to standardize OR Cameras to allow for the use of the OR Camera Cover

ASPEN SURGICAL PRODUCTS, INC.

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• Primary Device ID: 00840113219919
• NIH Device Record Key: 4b3221ba-1342-45f7-ab6f-1fda9781cbd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aspen® O.R. Camera Cover
• Version Model Number: LT-C01
• Company DUNS: 027680821
• Company Name: ASPEN SURGICAL PRODUCTS, INC.
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840113219919 [Package]; Contains: 00840113219926; Package: [10 Units]; In Commercial Distribution
GS1	00840113219926 [Primary]

FDA Product Code

• KQM: CAMERA, SURGICAL AND ACCESSORIES

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-05
• Device Publish Date: 2021-03-28

On-Brand Devices [Aspen® O.R. Camera Cover]

• 00840113219933: Aspen Surgical`s disposable camera cover will act as a sterile interface between the non-sterile
• 00840113219971: Intended to standardize OR Cameras to allow for the use of the OR Camera Cover
• 00840113219919: Intended to standardize OR Cameras to allow for the use of the OR Camera Cover