FDA UDI
In Commercial Distribution
🇺🇸 United States
QuiCover
DI: 06972060310532
·
Model: 0.3g
·
Hangzhou Zeo-Innov Life Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
8
Basic Information
- Brand Name
- QuiCover
- Primary DI
- 06972060310532
- Version / Model
- 0.3g
- Company Name
- Hangzhou Zeo-Innov Life Technology Co., Ltd.
- Labeler DUNS
- 541290694
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 8
- Record Status
- Published
- Publish Date
- 2024-04-22
- Public Version
- 1
- Public Version Date
- 2024-04-30
- Public Version Status
- New
- Public Device Record Key
- eda44c6d-71bc-4c62-be7f-a7038e6bf8e8
Device Description
The Zeolite Hemostatic Cotton consists of zeolite and cotton. It is provided in a sterile dressing format that conforms readily to the wound. There are 15 models of Zeolite Hemostatic Cotton, and the size ranges from 0.1g to 10g. The difference between each model is weight.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 47917 | Non-organic haemostatic agent | A non-bioabsorbable device made of mineral and/or synthetic polymer components (e.g., smectite, potassium ferrate/hydrophilic polymer) intended for application to a bleeding external epithelial wound [i.e., skin wound or gastrointestinal (GI) mucosa wound] to facilitate local haemostasis through formation of a sealant and/or clot acceleration; it might additionally be intended to absorb bodily fluids. It is available in various forms (e.g., powder, gel, impregnated gauze) intended to be applied directly or endoscopically to the wound temporarily; it does not contain an antimicrobial agent. Disposable manual or electronic devices for application may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06972060310532 | GS1 | ||||
| Package | 06972060310563 | GS1 | carton | 60 | In Commercial Distribution | |
| Unit of Use | 06972060310570 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223495 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 10 | Gram |