FDA UDI
In Commercial Distribution
🇺🇸 United States
HYGITECH
DI: 03615140000345
·
Model: HY-058
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HYGITECH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140000345
- Version / Model
- HY-058
- Catalog Number
- HY-058
- Company Name
- HYGITECH
- Labeler DUNS
- 279456896
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-15
- Public Version
- 1
- Public Version Date
- 2020-12-23
- Public Version Status
- New
- Public Device Record Key
- 17220d0f-25f0-42b6-a708-8beb85ada57a
Device Description
The surgeon, the assistant and the patient all have the potential to bring dust and bacteria into the operating room. The mat contains 30 disposable sheets. Simply peel off and dispose of each sheet when soiled. To prevent the spreading of bacterial contamination from room to room, HYGITECH has created a mat with an acrylic sticky surface treated with a substance which attacks and neutralises the bacterial content present in the residues retained by the mat. Advantages: - Non-slip PVC base - Numbered layers for checking the remaining capacity - Dimensions : 60x120cm
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FXP | Cover, Shoe, Operating-Room | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35582 | Decontamination floor mat, reusable | A pad made of coarse, durable material that is designed to be placed on the floor to wipe the soles of the footwear of persons walking on its surface. The product is intended to reduce the distribution of dirt/contaminated materials on the floor. This product can be reused after appropriate cleaning procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03615140000345 | GS1 |