| Primary Device ID | 00027479280009 |
| NIH Device Record Key | 6ec02c07-8e9a-411d-bf36-5368f72443af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Protective Mitts |
| Version Model Number | MTRM280 |
| Catalog Number | MTRM280 |
| Company DUNS | 063865158 |
| Company Name | MEDI-TECH INTERNATIONAL 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 414-570-8880 |
| Marilyn.Geiger@medi-techintl.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00027479280009 [Primary] |
| FMQ | Restraint, Protective |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2019-07-23 |
| 00027479280054 | Protective Mitts - Double Essential Secure - No Finger Separators - Adult One Size - Pair |
| 00027479280047 | Protective Mitts - Dependable Finger Control - Finger Separators - Adult One Size - Pair |
| 00027479280030 | Protective Mitts - Essential Secure - No Finger Separators - Adult One Size - Pair |
| 00027479280023 | Protective Mitts - Assured Control - Finger Separators - Adult One Size Pair |
| 00027479280016 | Protective Mitts - Easy View Double Padded -Adult One Size Pair |
| 00027479280009 | Protective Mitts - Soft Hand Guard - Adult One Size Pair |