FDA UDI
In Commercial Distribution
🇺🇸 United States
CALICO
DI: 00850044458554
·
Model: FD001
·
Calico Medical Group LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- CALICO
- Primary DI
- 00850044458554
- Version / Model
- FD001
- Catalog Number
- FD001
- Company Name
- Calico Medical Group LLC
- Labeler DUNS
- 118744421
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-08-22
- Public Version
- 1
- Public Version Date
- 2022-08-30
- Public Version Status
- New
- Public Device Record Key
- f4ab5b50-c6f6-4898-af48-3f07913990ea
Device Description
Non Adhesive Foam Dressing, PU Waterproof 2" x 2"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | 878.4018 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44970 | Exudate-absorbent dressing, non-gel, non-antimicrobial | A wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20850044458558 | GS1 | Case | 40 | In Commercial Distribution | |
| Primary | 00850044458554 | GS1 | ||||
| Unit of Use | 10850044458551 | GS1 |