INSPIRA
GUDID 04961333251858
PENTAX Medical Video Upper GI Scope EG29-i20c
HOYA CORPORATION
Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable| Primary Device ID | 04961333251858 |
| NIH Device Record Key | 366e127f-64ec-47be-b6e0-c7b390b845c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INSPIRA |
| Version Model Number | EG29-i20c |
| Company DUNS | 691519705 |
| Company Name | HOYA CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04961333251858 [Direct Marking] |
| GS1 | 04961333252145 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231249
FDA Product Code
| PEA | Endoscope, Accessories, Image Post-Processing For Color Enhancement |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04961333251858]
High-level Disinfectant;Liquid Chemical
[04961333251858]
High-level Disinfectant;Liquid Chemical
[04961333251858]
High-level Disinfectant;Liquid Chemical
[04961333251858]
High-level Disinfectant;Liquid Chemical
[04961333251858]
High-level Disinfectant;Liquid Chemical
[04961333251858]
High-level Disinfectant;Liquid Chemical
[04961333251858]
High-level Disinfectant;Liquid Chemical
[04961333251858]
High-level Disinfectant;Liquid Chemical
[04961333251858]
High-level Disinfectant;Liquid Chemical
[04961333251858]
High-level Disinfectant;Liquid Chemical
[04961333251858]
High-level Disinfectant;Liquid Chemical
[04961333251858]
High-level Disinfectant;Liquid Chemical
[04961333251858]
High-level Disinfectant;Liquid Chemical
[04961333251858]
High-level Disinfectant;Liquid Chemical
[04961333251858]
High-level Disinfectant;Liquid Chemical
[04961333251858]
High-level Disinfectant;Liquid Chemical
[04961333251858]
High-level Disinfectant;Liquid Chemical
[04961333251858]
High-level Disinfectant;Liquid Chemical
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-28 |
| Device Publish Date | 2023-09-20 |
On-Brand Devices [INSPIRA]
| 04961333247929 | PENTAX Medical Video Processor EPK-i8020c |
| 04961333251896 | PENTAX Medical Video Colonoscope EC38-i20cL |
| 04961333251858 | PENTAX Medical Video Upper GI Scope EG29-i20c |
| 04961333254934 | PENTAX Medical Video Processor EPK-i8020c (ORDER CODE: 90963) |
Trademark Results [INSPIRA]
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