FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Copioumed
DI: 04719882250415
·
Model: SCN0B101-1
·
COPIOUMED INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
150
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Basic Information
- Brand Name
- Copioumed
- Primary DI
- 04719882250415
- Version / Model
- SCN0B101-1
- Company Name
- COPIOUMED INTERNATIONAL INC.
- Labeler DUNS
- 658318113
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 150
- Record Status
- Published
- Publish Date
- 2022-09-02
- Public Version
- 2
- Public Version Date
- 2024-11-14
- Public Version Status
- Update
- Public Device Record Key
- d5437b93-32b7-4fd5-b1fe-3878c880ca37
- Distribution End Date
- 2024-09-23
Device Description
Copioumed Bouffant Cap provides an ideal headwear for a higher level of protection and comfort. The single-use cap features a latex-free elastic band around its circumference. This helps prevent allergic reactions that are due to exposure to latex . 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 | 14719882250412 | GS1 | Carton | 4 | Not in Commercial Distribution | 2024-09-23 |
| Primary | 04719882250415 | GS1 | ||||
| Unit of Use | 04719882250408 | GS1 |
Customer Contacts
- Phone
- +886227721815
- [email protected]