| Primary Device ID | 00634916796780 |
| NIH Device Record Key | a1d231e8-44de-4e61-b9e6-a0e96b100a2a |
| Commercial Distribution Discontinuation | 2023-02-28 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Isolation Gown |
| Version Model Number | 661YUA15 |
| Company DUNS | 006999858 |
| Company Name | STANDARD TEXTILE CO., INC. |
| Device Count | 1 |
| 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 |
| 00634916707038 - Pediatric Lap Drape | 2023-10-18 Pediatric Lap Drape, 1 Ply WrapPel Ripstop Body, 29x34 Reinforcement
Bound Pad (1 Ply Zorwick II, 1 Ply ComPel), 6" Triangular B |
| 00634916788358 - ComPel OR Gown | 2023-10-18 2-Ply Front/Sleeves Aqua Compel MLR and White ComPel MLR with
Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Nec |
| 00634916795493 - ProMax Surgical Gown | 2023-10-18 ProMax Surgical Gown, MLR Front Yoke, Comfort Panel Back with
Negastat, Snap Closures at Neck, Tape Tie Closures at Waist, With |
| 00634916857535 - ComPel Isolation Gown | 2023-10-18 Isolation Gown, ComPel, Yellow, Raglan
Sleeves, Metal Snaps at Neck and Waist,
Elastic Sleeve Opening and Thumb Loop |
| 00634916790528 - Isolation Gown EasyRelease | 2023-08-22 Isolation Gown EasyRelease, AAMI Level 1, generic polyester, Yellow, XL, Velcro Hook & Loop Closures at Neck/Waist, Long Sleeves |
| 10634916508960 - DermaTherapy Fitted Sheet | 2023-07-28 DermaTherapy Fitted Sheet, 50% Polyester / 50% Nylon, Encased Elastic
Hem all Around, 37x79x10 |
| 10634916578710 - DermaTherapy Fitted Sheet | 2023-07-28 DermaTherapy Fitted Sheet, 50% Polyester / 50% Nylon, Encased Elastic
Hem all Around with Blue Thread, 35x84x11 |
| 00634916796780 - Isolation Gown | 2023-07-03Isolation Gown, AAMI Level 2, Reusable, 100% Polyester, Tie Closures Neck and Waist, Raglan Sleeves with Poly Cuffs |
| 00634916796780 - Isolation Gown | 2023-07-03 Isolation Gown, AAMI Level 2, Reusable, 100% Polyester, Tie Closures Neck and Waist, Raglan Sleeves with Poly Cuffs |