| Primary Device ID | 00850061859112 |
| NIH Device Record Key | b42b18fb-4ae6-4e0a-acfd-080482065811 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GCB Medical Supply Novaplus |
| Version Model Number | VGCB1450 |
| Catalog Number | VGCB1450 |
| Company DUNS | 086699722 |
| Company Name | GCB MEDICAL LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | (833) 422-6331 |
| info@gcbmedicalsupply.com | |
| Phone | (833) 422-6331 |
| info@gcbmedicalsupply.com | |
| Phone | (833) 422-6331 |
| info@gcbmedicalsupply.com | |
| Phone | (833) 422-6331 |
| info@gcbmedicalsupply.com | |
| Phone | (833) 422-6331 |
| info@gcbmedicalsupply.com | |
| Phone | (833) 422-6331 |
| info@gcbmedicalsupply.com | |
| Phone | (833) 422-6331 |
| info@gcbmedicalsupply.com | |
| Phone | (833) 422-6331 |
| info@gcbmedicalsupply.com | |
| Phone | (833) 422-6331 |
| info@gcbmedicalsupply.com | |
| Phone | (833) 422-6331 |
| info@gcbmedicalsupply.com | |
| Phone | (833) 422-6331 |
| info@gcbmedicalsupply.com | |
| Phone | (833) 422-6331 |
| info@gcbmedicalsupply.com | |
| Phone | (833) 422-6331 |
| info@gcbmedicalsupply.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850061859013 [Primary] |
| GS1 | 00850061859112 [Package] Contains: 00850061859013 Package: case [10 Units] In Commercial Distribution |
| OEA | Non-Surgical Gown |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-31 |
| Device Publish Date | 2025-07-23 |
| 00850061859143 | GCB MEDICAL NOVAPLUS SURGEON CAP |
| 00850061859136 | GCB MEDICAL NOVAPLUS UNIVERSAL, NON SKID SHOE COVER |
| 00850061859129 | GCB MEDICAL NOVAPLUS BLUE BOUFFANT, LATEX FREE ELASTIC |
| 00850061859112 | GCB MEDICAL NOVAPLUS AAMI LEVEL 2 SMS UNIVERSAL ISOLATION GOWN |