FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Copioumed
DI: 04719882250477
·
Model: SCN0B201-1
·
COPIOUMED INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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
- Copioumed
- Primary DI
- 04719882250477
- Version / Model
- SCN0B201-1
- Company Name
- COPIOUMED INTERNATIONAL INC.
- Labeler DUNS
- 658318113
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2022-08-31
- Public Version
- 2
- Public Version Date
- 2024-11-14
- Public Version Status
- Update
- Public Device Record Key
- 61ef8970-243d-42e0-bc91-d30f8f3244c1
- Distribution End Date
- 2024-09-23
Device Description
Copioumed Surgical Cap with Ties offers a comfortable and enhanced fit for wearers, as it is equipped with ties on the back for an adjustable size. The wide-forehead surgical cap’s design also ensures a close fit, especially for people with long hair. In addition, the wide and flat forehead contains no elastic, so this surgical cap won’t leave a mark. Which offers protection against particles- and hair-related cross-contamination, making it the preferred line for the operating theatre.
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
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 14719882250474 | GS1 | Carton | 5 | Not in Commercial Distribution | 2024-09-23 |
| Primary | 04719882250477 | GS1 | ||||
| Unit of Use | 04719882250460 | GS1 |
Customer Contacts
- Phone
- +886227721815
- [email protected]