Mongoose
GUDID 74543527226201
TOGO MEDIKIT CO.,LTD.
Angiographic catheter, single-use| Primary Device ID | 74543527226201 |
| NIH Device Record Key | bca24c6f-5c2a-4ab3-8655-dfa261d635b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mongoose |
| Version Model Number | A-4JR1-80/0017 |
| Company DUNS | 690724240 |
| Company Name | TOGO MEDIKIT CO.,LTD. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store this product in a cool, dark, dry place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04543527226202 [Primary] |
| GS1 | 14543527226209 [Package] Contains: 04543527226202 Package: Box [3 Units] In Commercial Distribution |
| GS1 | 74543527226201 [Package] Contains: 14543527226209 Package: Carton [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113819
FDA Product Code
| DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-16 |
On-Brand Devices [Mongoose]
Trademark Results [Mongoose]
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