PENDING

Basic Information

• Brand Name: PENDING
• Primary DI: 10080196013128
• Version / Model: MPN50012
• Catalog Number: MPN50012
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-21
• Public Version: 1
• Public Version Date: 2020-08-31
• Public Version Status: New
• Public Device Record Key: cc00e7e2-be58-4f8f-985d-d4d3eeab0508

Device Description

TISSUE PROTECTOR, 2.8MM/3.5MM

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33385	Nerve guide, non-bioabsorbable	An implantable tubular device, typically made of silicone rubber, intended to be used to encase a nerve for protection to aid in repair (e.g., to prevent ingrowth of scar tissue), or for capping the end of an amputated nerve to prevent the formation of painful neuroma (tumours). It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, or a nerve wrap.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10080196013128	GS1

Customer Contacts

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