Aspen® Flexible Light Handle Adapter

GUDID 00840113208357

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

ASPEN SURGICAL PRODUCTS, INC.

Light source adaptor

• Primary Device ID: 00840113208357
• NIH Device Record Key: d551c83d-0d6d-44bf-81a6-2096c7279ec2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aspen® Flexible Light Handle Adapter
• Version Model Number: LT-9508X
• 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	00840113208357 [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.