Batrik Sheet Tape\8.5x11\W-Lavender

Basic Information

• Brand Name: Batrik Sheet Tape\8.5x11\W-Lavender
• Primary DI: 00690521003514
• Version / Model: T-850-4-11
• Catalog Number: T-850-4-11
• Company Name: Batrik Medical Manufacturing Inc
• Labeler DUNS: 243880700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-28
• Public Version: 1
• Public Version Date: 2021-11-05
• Public Version Status: New
• Public Device Record Key: 1ef83e10-7531-46de-b5d0-c4574073ad3c

Device Description

Identification Sheet Tape, White/Lavender stripes, contains different size adhesive strips

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: 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: Yes
• 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
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47285	Auditory brainstem implant system	An assembly of electronic devices intended to restore useful hearing to a deaf patient via electrical stimulation of the brainstem's cochlear nucleus. It typically includes an external speech processor and microphone/headset to transform acoustical signals into an electrical code, which is transmitted from the headset to a surgically implanted receiver-stimulator where it is decoded and delivered to a multichannel electrode array. The array is surgically placed on the cochlear nucleus, which when stimulated results in the signal's transmission to the brain where it is interpreted as sound. An auditory brainstem implant (ABI) is used to treat deafness resulting from auditory nerve tumours.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690521003514	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight