AccessGUDID - DEVICE: Medicom SafeGauze (10686864055089)

GUDID

Device Identifier (DI) Information

Brand Name: Medicom SafeGauze
Version or Model: 4900-STAT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4900-STAT
Company Name: AMD Medicom Inc

Primary DI Number: 10686864055089
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173196	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 0.75 x 0.75 Inch

Device Record Status

Public Device Record Key: 3b3c4d94-eecf-41cf-8155-0f526ae761c4
Public Version Date: May 07, 2024
Public Version Number: 11
DI Record Publish Date: October 05, 2017