FDA UDI
In Commercial Distribution
🇺🇸 United States
GCB Medical Supply Novaplus
DI: 00850061859020
·
Model: VGCB0210
·
GCB MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- GCB Medical Supply Novaplus
- Primary DI
- 00850061859020
- Version / Model
- VGCB0210
- Catalog Number
- VGCB0210
- Company Name
- GCB MEDICAL LLC
- Labeler DUNS
- 086699722
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-23
- Public Version
- 1
- Public Version Date
- 2025-07-31
- Public Version Status
- New
- Public Device Record Key
- 32ff03f8-ba56-4840-b994-079264bd8364
Device Description
GCB MEDICAL NOVAPLUS BLUE BOUFFANT, LATEX FREE ELASTIC
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
- No
- 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 |
|---|---|---|---|---|---|---|
| Package | 00850061859129 | GS1 | case | 10 | In Commercial Distribution | |
| Primary | 00850061859020 | GS1 |
Customer Contacts
- Phone
- (833) 422-6331
- [email protected]