Versapro MS2115
GUDID 20842472100208
PROCEDURE EARLOOP MASK PLEATED BLUE
MEDICAL SPECIALTIES DISTRIBUTORS, LLC
Surgical/medical face mask, single-use| Primary Device ID | 20842472100208 |
| NIH Device Record Key | dcf37c9e-79de-4a9e-913d-d7229f675bcf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Versapro |
| Version Model Number | MS2115 |
| Catalog Number | MS2115 |
| Company DUNS | 153608369 |
| Company Name | MEDICAL SPECIALTIES DISTRIBUTORS, LLC |
| 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 | 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842472100204 [Primary] |
| GS1 | 10842472100201 [Package] Contains: 00842472100204 Package: Inner Pack [50 Units] In Commercial Distribution |
| GS1 | 20842472100208 [Package] Contains: 10842472100201 Package: Case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051291
FDA Product Code
| FXX | Mask, Surgical |
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 | 2020-05-06 |
| Device Publish Date | 2016-12-06 |
Devices Manufactured by MEDICAL SPECIALTIES DISTRIBUTORS, LLC
| 20842472100208 - Versapro | 2020-05-06PROCEDURE EARLOOP MASK PLEATED BLUE |
| 20842472100208 - Versapro | 2020-05-06 PROCEDURE EARLOOP MASK PLEATED BLUE |
| 10842472106777 - MedStream | 2020-05-06 BEARD COVERS STERILE 10PK |
| 00842472106992 - MedStream | 2020-03-09 |
| 10842472107002 - MedStream | 2020-03-09 |
| 00842472107012 - MedStream | 2020-03-09 |
| 10842472107026 - MedStream | 2020-03-09 |
| 10842472107033 - MedStream | 2020-03-09 |
| 10842472107101 - MedStream | 2019-12-11 DRESSING CHANGE KIT |
Trademark Results [Versapro]
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