FDA UDI
In Commercial Distribution
🇺🇸 United States
BE SMART GET PREPARED
DI: 00020424080013
·
Model: 00-GAU-8001YOU
·
TOTAL RESOURCES INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BE SMART GET PREPARED
- Primary DI
- 00020424080013
- Version / Model
- 00-GAU-8001YOU
- Catalog Number
- 00-GAU-8001YOU
- Company Name
- TOTAL RESOURCES INTERNATIONAL INC.
- Labeler DUNS
- 790160535
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-13
- Public Version
- 2
- Public Version Date
- 2025-01-07
- Public Version Status
- Update
- Public Device Record Key
- e0d4c27d-f93b-4dfa-a664-4274ab7fab05
Device Description
Be Smart Get Prepared® Blood Stopping (Hemostatic Gauze) 4” x 4” 1/ply/ 1 pc
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | 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 |
|---|---|---|---|---|---|---|
| Primary | 00020424080013 | GS1 |