Aspen® Flexible Light Handle Adapter

GUDID 00840113208500

Intent to be used with Aspen Surgical Disposable light Handle covers.

ASPEN SURGICAL PRODUCTS, INC.

Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor

• Primary Device ID: 00840113208500
• NIH Device Record Key: fb028af5-2731-4433-9ddd-a53f01d74315
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aspen® Flexible Light Handle Adapter
• Version Model Number: LT-9567X
• Company DUNS: 027680821
• Company Name: ASPEN SURGICAL PRODUCTS, INC.
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840113208500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020304

FDA Product Code

• FTA: Light, surgical, accessories

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: 2021-03-05
• Device Publish Date: 2021-02-25

On-Brand Devices [Aspen® Flexible Light Handle Adapter]

• 00887761021464: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761010680: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761010673: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761010666: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761010659: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761010642: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761010635: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761010628: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761010611: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761010604: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761010598: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761010581: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761010574: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761010567: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761010550: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761010543: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 10887761009544: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 10887761009537: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761009523: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761009516: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761009509: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 10887761009490: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761009486: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761009479: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761009462: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761009455: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761009448: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 10887761009438: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761009424: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 10887761009414: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761009400: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 10887761009391: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 10887761009384: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761009370: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761009363: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761009356: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 10887761009346: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 10887761009339: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 10887761009322: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 10887761009315: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761009301: Single used Intent to be used as a sterile interface between the non-sterile Surgical Light and
• 00887761009295: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 10887761009285: Single used Intent to be used as a sterile interface between the non-sterile Surgical Light and
• 10887761009278: Single used Intent to be used as a sterile interface between the non-sterile Surgical Light and
• 10887761009261: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 10887761009254: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761009240: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 10887761009230: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761009226: Intent to be used with Aspen Surgical Disposable light Handle covers.
• 00887761009219: Intent to be used with Aspen Surgical Disposable light Handle covers.