| Primary Device ID | 10864666000326 |
| NIH Device Record Key | 797e0213-1102-48ba-b490-13f98ea1718b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medical Science Products |
| Version Model Number | 4040-SD |
| Catalog Number | 4040-SD |
| Company DUNS | 080557421 |
| Company Name | SAUVRE INTERNATIONAL, LTD. |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | true |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Width | 40 Millimeter |
| Length | 40 Millimeter |
| Width | 40 Millimeter |
| Length | 40 Millimeter |
| Width | 40 Millimeter |
| Length | 40 Millimeter |
| Width | 40 Millimeter |
| Length | 40 Millimeter |
| Width | 40 Millimeter |
| Length | 40 Millimeter |
| Width | 40 Millimeter |
| Length | 40 Millimeter |
| Width | 40 Millimeter |
| Length | 40 Millimeter |
| Width | 40 Millimeter |
| Length | 40 Millimeter |
| Width | 40 Millimeter |
| Length | 40 Millimeter |
| Width | 40 Millimeter |
| Length | 40 Millimeter |
| Width | 40 Millimeter |
| Length | 40 Millimeter |
| Width | 40 Millimeter |
| Length | 40 Millimeter |
| Width | 40 Millimeter |
| Length | 40 Millimeter |
| Width | 40 Millimeter |
| Length | 40 Millimeter |
| Width | 40 Millimeter |
| Length | 40 Millimeter |
| Width | 40 Millimeter |
| Length | 40 Millimeter |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00864666000305 [Primary] |
| GS1 | 00864666000312 [Package] Contains: 00864666000305 Package: Bag [4 Units] In Commercial Distribution |
| GS1 | 00864666000329 [Package] Contains: 00864666000305 Package: Bag [24 Units] In Commercial Distribution |
| GS1 | 10864666000319 [Package] Contains: 00864666000312 Package: Box [400 Units] In Commercial Distribution |
| GS1 | 10864666000326 [Package] Contains: 00864666000329 Package: Box [120 Units] In Commercial Distribution |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-06-08 |
| 00864666000367 | Transcutaneous electrical stimulation electrode, Butterfly, 110x150mm, Foam material |
| 10851610008002 | Transcutaneous electrical stimulation electrode, Square, 50x90mm, Foam material |
| 10864666000395 | Transcutaneous electrical stimulation electrode, Square, 50x50mm, Foam material |
| 10864666000326 | Transcutaneous electrical stimulation electrode, Square, 40x40mm |
| 00851610008326 | Analog TENS device |
| 10851610008347 | Digital TENS device |
| 10851610008026 | Transcutaneous electrical stimulation electrode, Square, 50x50mm, Cloth material |