| Primary Device ID | 05030267044443 |
| NIH Device Record Key | 6f2a2f85-4fde-4ba2-90cc-8f29b63033b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ONE-PIECE GUEDEL AIRWAY, SIZE 00, ISO 5 |
| Version Model Number | 1100050 |
| Company DUNS | 785952607 |
| Company Name | Intersurgical Incorporated |
| 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 | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05030267044443 [Package] Contains: 05030267050185 Package: [25 Units] In Commercial Distribution |
| GS1 | 05030267044450 [Package] Contains: 05030267050185 Package: [100 Units] In Commercial Distribution |
| GS1 | 05030267050185 [Primary] |
| CAE | Airway, Oropharyngeal, Anesthesiology |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-02 |
| Device Publish Date | 2023-05-25 |
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