| Primary Device ID | 00634916019360 |
| NIH Device Record Key | 545a96e0-1958-4290-9bd0-ccf3aba8b008 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ComPel Surgical Gowns |
| Version Model Number | 7556103F |
| Catalog Number | 7556103F |
| Company DUNS | 006999858 |
| Company Name | STANDARD TEXTILE CO., INC. |
| Device Count | 24 |
| 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 | 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 | 00634916019360 [Primary] |
| GS1 | 10634916019360 [Unit of Use] |
| FYA | Gown, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
[00634916019360]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2018-01-29 |
| 00634916019353 - Standard Supreme | 2026-03-19 Instrument Drape, 2 Ply Standard Supreme, 5% COTTON, 45% POLYESTER |
| 00634916099225 - INSTRUMENT COVER | 2026-03-19 Instrument Cover, 2 Ply T-180, 55% Cotton, 45% Polyester |
| 00634916120905 - Instrument Holder | 2026-03-19 Wrappel Instrument Holder with Pockets, 100% Polyester |
| 00634916349740 - Compel MLR OR Gown | 2026-03-19 Compel MLR OR Gown, Snap Closures at Neck, 100% POLYESTER. |
| 00634916781373 - WrapPel Table Cover | 2026-03-19 WrapPel Table Cover with Pad (1 Ply), 100% POLYESTER' |
| 00634916788105 - Compel MLR OR Gown | 2026-03-19 Compel MLR OR Gown 2-Ply Front/Sleeves, Tie, 100% POLYESTER. |
| 00634916788112 - Compel MLR OR Gown | 2026-03-19 Compel MLR OR Gown 2-Ply Front/Sleeves, Tie, 100% POLYESTER. |
| 00634916788129 - Compel MLR OR Gown | 2026-03-19 Compel MLR OR Gown, 2-Ply Front/Sleeves, Tie 100% POLYESTER |