| Primary Device ID | 00634916021363 |
| NIH Device Record Key | 445ae5f9-ec47-46f1-9dec-4e98565e114e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXCEL PLUS COMPLY PAD |
| Version Model Number | 6106472H |
| Catalog Number | 6106472H |
| Company DUNS | 006999858 |
| Company Name | STANDARD TEXTILE CO., INC. |
| Device Count | 24 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00634916021363 [Primary] |
| GS1 | 10634916021360 [Unit of Use] |
| GS1 | 10634916021363 [Unit of Use] |
| FMW | Cover, Mattress (Medical Purposes) |
| 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 | 2018-01-29 |
| 00634916302486 | EXCEL PLUS COMPLY PAD KAUM 30X36 RM (98 8303) USE: 61064100 |
| 00634916070262 | EXCEL PLUS COMPLY PAD KAUM 30X36 RM (98 7440) USE: 61064210 |
| 00634916027617 | EXCEL PLUS COMPLY PAD KAUM 30X36 RM (98 8176) USE: 61064210 |
| 00634916021363 | EXCEL PLUS COMPLY PAD KAUM 30X36 RM (98 8119) USE: 61064210 |