AccessGUDID - DEVICE: Medicom SafeGauze (20686864054683)

GUDID

Device Identifier (DI) Information

Brand Name: Medicom SafeGauze
Version or Model: SP-4900
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SP-4900
Company Name: AMD Medicom Inc

Primary DI Number: 20686864054683
Issuing Agency: GS1
Commercial Distribution End Date: September 18, 2023
Device Count: 2
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: SAFEGAUZE HEMOSTAT STERILE - TOPICAL DENTAL DRESSING - 4PLY - 0.75" X 0.75" - WHITE - Sample Pack

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: Store in a cool dry place - Temperature between 5 and 40°C

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: 3a9381fe-873f-4ec4-a811-923b6683432a
Public Version Date: September 19, 2023
Public Version Number: 11
DI Record Publish Date: March 23, 2018