AMD-RITMED ALL GAUZE

Basic Information

• Brand Name: AMD-RITMED ALL GAUZE
• Primary DI: 10686864053252
• Version / Model: B8125
• Catalog Number: B8125
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2019-01-14
• Public Version: 2
• Public Version Date: 2021-08-24
• Public Version Status: Update
• Public Device Record Key: 78a86b95-e860-4208-9cc3-c52e4c6dec24

Device Description

AMD-RITMED ALL GAUZE SPONGE 12 PLY 8 X 4 Inch

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAC	Dressing, wound, hydrophilic	General, Plastic Surgery	878.4018	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48134	Woven gauze pad	A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	12686864053250	GS1	Tray	10	In Commercial Distribution
Primary	10686864053252	GS1
Package	20686864053259	GS1	Outer Case	20	In Commercial Distribution
Unit of Use	00686864053255	GS1

Customer Contacts

• Phone: [phone] ext. 2309
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			8 X 4 Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Cool dry place