| Primary Device ID | 20886333224191 |
| NIH Device Record Key | d102ac98-9457-42ec-83ac-2913c50d4b99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | General Biopsy Tray |
| Version Model Number | GUTS1000LF |
| Catalog Number | GUTS1000LF |
| Company DUNS | 140727624 |
| Company Name | ARGON MEDICAL DEVICES, INC. |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Phone | 1.800.927.4669 |
| Customer.Service@argonmedical.com | |
| Phone | 1.800.927.4669 |
| Customer.Service@argonmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886333224197 [Primary] |
| GS1 | 20886333224191 [Package] Contains: 00886333224197 Package: Box [5 Units] In Commercial Distribution |
| KNW | Instrument, Biopsy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-05-28 |
| Device Publish Date | 2018-04-25 |
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