| Primary Device ID | 00634916040043 |
| NIH Device Record Key | 726aeae8-3591-4f53-886c-be56c4348245 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ComPel Surgical Gown |
| Version Model Number | 75654975 |
| Catalog Number | 75654975 |
| 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 | 00634916040043 [Primary] |
| GS1 | 10634916040043 [Unit of Use] |
| FYA | Gown, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
Moist Heat or Steam Sterilization
[00634916040043]
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 |
| 00634916386196 | COMPEL, BERYL GREEN, L, 2 PLY FRONT/SLV TTIES (SR19498) |
| 00634916343274 | SURG GWN ULT CMP NEGA GREEN L - 2PLY FRT/SLV TIES NK/WST |
| 00634916343250 | OR Gown ComPel NEG BK BLUE L/XL |
| 00634916343236 | OR GWN CMPL MISTY XL - TT @ NK NEGAST BK (SR 13404) |
| 00634916343175 | OR GWN CMPL BL L - TT @ NK NEGAST BK |
| 00634916325881 | OR GWN COMPEL NEGA BL KAUM L - RM (98 8305) USE: 75656695 |
| 00634916318784 | SURG GWN COMPEL GREEN M - 2PLY FRT/SLV TTIES (SR 17948) |
| 00634916318760 | SURG GWN COMPEL GREEN L - 2PLY FRT/SLV TTIES (SR 17948) |
| 00634916302677 | OR GWN COMPEL NEGA KAUM BL 2XL - RM (98 8305) USE: 75656693 |
| 00634916298048 | OR GWN ULT COMPEL KAUM BL XL - RM (98 8305) USE: 75656694 |
| 00634916294989 | OR GOWN COMPEL NEG KAUM BLU L/XL - RM (98 8282) USE: 75658785 |
| 00634916284539 | SURG GWN COMPEL KAUM GREEN M - 2PLY FRT/SLV TTIES (SR 17593) |
| 00634916230437 | OR GWN CMPL NEGA KAUM BL 3XL - RM (98 8203) USE: 75656692 |
| 00634916230420 | OR GWN CMP KAUM BL 2X - RM (98 8203) USE: 75658783 |
| 00634916230413 | OR GWN CMP KAUM BK BLU L/XL - RM (98 8203) USE: 75658785 |
| 00634916229998 | OR GWN ULT COMPEL NEGA BL 2XL - 2PLY FRT/SLV SNAP NK (SR16569) |
| 00634916229981 | OR GWN ULT COMPEL NEGA BL XL - 2PLY FRT/SLV SNAP NK (SR16991) |
| 00634916229974 | OR GWN ULT COMPEL NEGA BL L - 2PLY FRT/SLV SNAP NK (SR16991) |
| 00634916227031 | SURGICAL COMPEL KAUM GREEN L - 2PLY FRT/SLV TTIES (SR 16820) |
| 00634916188226 | OR GWN COMPEL KAUM BK BLU L/XL - RM (98 8131) USE: 75658785 |
| 00634916147636 | OR GWN CMP NEG BK BLUE L/XL - SHORT 2PLY MS @ NK W/BARCODE |
| 00634916147629 | OR GWN CMP NEG BK KAU BLU L/XL - RM (98-8282) MEMORIAL HERMANN |
| 00634916147605 | OR GWN COMPEL KAUM BLUE 3XL - RM (98-8282) MEMORIAL HERMANN |
| 00634916146639 | OR GWN COMPEL NEG BK BLUE 3XL - 2PLY MS @ NK TIE WST W/BARCODE |
| 00634916141894 | OR GWN CMP NEG BK BLUE 2XL - 2PLY MS @ NK TIE WST W/BARCODE |
| 00634916141887 | OR GWN COMPEL NEG BK BLUE L/XL - 2PLY MS @ NK TIE WST W/BARCODE |
| 00634916137224 | OR GWN ULT COMPEL NEGA BL 2XL - 1PLY FRT/SLV (SR 15877) |
| 00634916137217 | OR GWN ULT COMPEL NEGA BL XL - 1PLY FRT/SLV (SR 15877) |
| 00634916137163 | OR GWN ULT COMPEL NEGA BL L - 1PLY FRT/SLV (SR 15877) |
| 00634916110159 | SURGICAL GOWN COMPEL BLUE L - 1PLY FRT/SLV (S/R 14987) |
| 00634916108316 | OR GWN COMPEL NEGA KAUM BL L - RM (98 7779) USE: 75656695 |
| 00634916084184 | OR GOWN COMPEL NGA BK KAUM L/XL - RM (98 7434) USE:75658785 BLUE |
| 00634916056310 | SURG GWN ULT CMPL NEGA BL 2XL - 2PLY FRT/SLV-BL NK-TIE NK/WST |
| 00634916051650 | ENDOSCOPY GOWN COMPEL MISTY L - POLY TIE NK/WST (S/R 12568) |
| 00634916048124 | OR GWN ULT CMPL XL KAU NEGA BL - RM (98 7181) USE: 75656694 |
| 00634916048117 | OR GWN ULT CMPL L KAUM NEGA BL - RM (98 7181) USE: 75656695 |
| 00634916043211 | OR GWN FULL BARRIER CEIL M - TT @ WST W/BCODE S/R 11940 |
| 00634916040043 | OR GWN CMPL NEGA BK BLUE L/XL - 2PLY (S/R 11851) |
| 00634916033236 | SURG GWN ULT COMPEL NEGA BL L - 2PLY FRT/SLV-BL NK-TIE NK/WST |
| 00634916033229 | SURG GWN ULT CMPL NEGA BL XL - 2PLY FRT/SLV-BL NK-TIE NK/WST |
| 00634916028416 | OR GWN ULT CMPL NEGA BL XL - 2PLY FRT-MS @ NK/WST SR 11109 |
| 00634916026085 | SURG GWN ULT CMPL NEGA BL 2XL - RM (98 2969) USE: 75656693 |
| 00634916025262 | OR GWN FULL BARRIER GREEN XL - TT @ NK/WST W/BCODE S/R 10880 |
| 00634916024470 | SURGICAL GWN COMPEL BL 2XL - SNAP NK/TIE WST (S/R 10720) |
| 00634916024456 | OR GWN CMPL NEGA BK BLUE 2XL - RM (98 8282) USE: 75658783 |
| 00634916024449 | OR GWN CMPL NEGA BK BLUE L/XL - RM (98 8282) USE: 75658785 |
| 00634916016741 | SURG GWN ULT CMPL NEGA BL XL - 2PLY FRT/SLV-BL NK-TIE NK/WST |
| 00634916011296 | SURG GWN ULT CMP NEGA BL L IMP - 2PLY FRT/SLV-BL NK-TIE NK/WST |
| 00634916010923 | OR GWN CMPL TEAL XL - MS NK-MS TIES @ WST S/R 9338Y |
| 00634916006018 | OR GWN CMPL ULT NEGA BL 3XL - TT NK/WST 2PLY FRNT/SLV QCM 3 |