TUTEM

Basic Information

• Brand Name: TUTEM
• Primary DI: 00817583020437
• Version / Model: 6055-9 BABY BOY
• Catalog Number: 6055-9 BABY BOY
• Company Name: ALPHA PRO TECH INC
• Labeler DUNS: 003687733
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-03
• Public Version: 6
• Public Version Date: 2023-04-20
• Public Version Status: Update
• Public Device Record Key: 01897789-f853-4431-a3d0-d5722da0843b
• Distribution End Date: 2023-04-19

Device Description

EARLOOP, TUTEM-BABY BOY

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: 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
FXX	Mask, Surgical	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43315	Surgical hood	A non-sterile head covering designed as a top with elongated sides and back with a front opening for the face to be used by surgical staff to cover their hair and facial hair (beards) in order to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is typically made of soft, disposable materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10817583020434	GS1	CASE	3000	Not in Commercial Distribution	2023-04-19
Primary	00817583020437	GS1

Customer Contacts

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