Aspen ® Protecto Tape Card

Basic Information

• Brand Name: Aspen ® Protecto Tape Card
• Primary DI: 00887761000841
• Version / Model: 713000
• Company Name: ASPEN SURGICAL PRODUCTS, INC.
• Labeler DUNS: 027680821
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2019-05-31
• Public Version: 3
• Public Version Date: 2021-03-04
• Public Version Status: Update
• Public Device Record Key: eaac6b3b-4382-41e7-a36f-9d58795773f9

Device Description

Intended for skin closure and closure support for sutures and staples

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPX	Strip, adhesive, closure, skin	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32207	Skin-closure adhesive strip	A small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887761000841	GS1
Unit of Use	80887761000847	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K874813	000