FDA UDI
In Commercial Distribution
🇺🇸 United States
HUANFU
DI: 26974239590053
·
Model: light blue
·
Hubei Huanfu Plastic Products Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1200
Basic Information
- Brand Name
- HUANFU
- Primary DI
- 26974239590053
- Version / Model
- light blue
- Company Name
- Hubei Huanfu Plastic Products Co., Ltd.
- Labeler DUNS
- 530032259
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1200
- Record Status
- Published
- Publish Date
- 2023-01-05
- Public Version
- 1
- Public Version Date
- 2023-01-13
- Public Version Status
- New
- Public Device Record Key
- 15181ac2-6d09-4a1f-97e4-02b849b27ee6
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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FYF | Cap, Surgical | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32297 | Surgical cap, single-use | A head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 06974239590004 | GS1 | ||||
| Primary | 26974239590053 | GS1 |