AllCare, INC

Basic Information

• Brand Name: AllCare, INC
• Primary DI: 00182921000182
• Version / Model: ORBX-100
• Catalog Number: ORBX-100
• Company Name: ALLCARE, INC
• Labeler DUNS: 362187580
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-01-16
• Public Version: 1
• Public Version Date: 2022-01-24
• Public Version Status: New
• Public Device Record Key: afe32734-ff4b-4d02-aa34-5f4cf6910951

Device Description

OR TOWEL, BLUE, X-RAY DETECTABLE, COTTON, PRE-WASHED, NON-STERILE, 100/CASE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Sterilization Methods: ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRL	Fiber, Medical, Absorbent	General Hospital	880.5300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14077	Surgical towel	A sterile cloth used in the operating room (OR) to absorb extraneous fluids. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00182921000205	GS1
Primary	00182921000182	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 30 Degrees Celsius