AccessGUDID - DEVICE: BE SMART GET PREPARED (00020424080013)

GUDID

Device Identifier (DI) Information

Brand Name: BE SMART GET PREPARED
Version or Model: 00-GAU-8001YOU
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-GAU-8001YOU
Company Name: TOTAL RESOURCES INTERNATIONAL INC.

Primary DI Number: 00020424080013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790160535 *Terms of Use

Device Description: Be Smart Get Prepared® Blood Stopping (Hemostatic Gauze) 4” x 4” 1/ply/ 1 pc

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e0d4c27d-f93b-4dfa-a664-4274ab7fab05
Public Version Date: January 07, 2025
Public Version Number: 2
DI Record Publish Date: December 13, 2024