Medicom SafeGauze

Basic Information

• Brand Name: Medicom SafeGauze
• Primary DI: 10686864055089
• Version / Model: 4900-STAT
• Catalog Number: 4900-STAT
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2017-10-05
• Public Version: 10
• Public Version Date: 2023-05-26
• Public Version Status: Update
• Public Device Record Key: 3b3c4d94-eecf-41cf-8155-0f526ae761c4

Device Description

Medicom SafeGauze HemoStat - Topical Dental Dressing - Sterile - 4 Ply - White 0.75" x 0.75"

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58059	Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial	A non-bioabsorbable device derived from plant polysaccharides [e.g., micro-dispersed oxidized cellulose (M-Doc), oxidized regenerated cellulose (ORC), calcium alginate] intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound, to facilitate local haemostasis; it does not contain an antimicrobial agent. It is available in various forms (e.g., gel, spray, powder, ointment, plaster/gauze pad, fibre/wool) that can be applied directly to the wound where it forms a seal until removed. The device is intended for use in the home or healthcare facility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20686864055086	GS1	Outer Case	200	In Commercial Distribution
Primary	10686864055089	GS1
Unit of Use	00686864055082	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173196	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.75 x 0.75 Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Between 5°C and 40°C (i.e. between 41°F and 104°F)