DeRoyal
GUDID 50749756566105
GWN XLG STD NON-REIN
DEROYAL INDUSTRIES, INC.
Surgical gown, single-use| Primary Device ID | 50749756566105 |
| NIH Device Record Key | deb82844-6d43-493e-8280-0a9f8102ef3f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DeRoyal |
| Version Model Number | 99-18413-D |
| Company DUNS | 096372255 |
| Company Name | DEROYAL INDUSTRIES, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com | |
| Phone | +1(888)938-7828 |
| udisupport@deroyal.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00749756566100 [Primary] |
| GS1 | 50749756566105 [Package] Contains: 00749756566100 Package: Case [25 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K070431
FDA Product Code
| FYA | GOWN, SURGICAL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2016-09-12 |
On-Brand Devices [DeRoyal]
| 50749756891016 | LAPAROSCOPY PELVISCOPY PACK |
| 50749756890248 | CARDIAC CATH PACK 106TH ST |
| 50749756889686 | GENERAL LAPAROSCOPY PACK |
| 50749756889600 | CARDIAC CATH PACK |
| 00749756889476 | PRO II w/GPS |
| 50749756889358 | CATH LAB PACK |
| 50749756889020 | ANGIOGRAPHY PACK |
| 50749756888900 | ANGIO PACK |
| 50749756886746 | Electrosurgical Pencil |
| 50749756886739 | Electrosurgical Pencil |
| 50749756886722 | Electrosurgical Pencil |
| 50749756886692 | Electrosurgical Pencil |
| 00749756885546 | CoolJet Cold Therapy Unit |
| 00749756885539 | CoolJet Cold Therapy Unit |
| 00749756885522 | CoolJet Cold Therapy Unit |
| 00749756885515 | CoolJet Cold Therapy Unit |
| 00749756885508 | CoolJet Cold Therapy Unit |
| 00749756885492 | CoolJet Cold Therapy Unit |
| 00749756885485 | CoolJet Cold Therapy Unit |
| 00749756885478 | CoolJet Cold Therapy Unit |
| 00749756885461 | CoolJet Cold Therapy Unit |
| 50749756885442 | Neo. Temp Probe 12 Pink |
| 50749756885435 | Neo. Temp Probe 11 Putty |
| 50749756885398 | Neo. Temp Probe 10 Green |
| 50749756885381 | Neo. Temp Probe 3 Orange |
| 50749756885329 | Neo. Temp Probe 1 Purple |
| 50749756884384 | PARK WEST MANIFOLD KIT |
| 50749756884056 | Universal Smoke Evac Attachment |
| 50749756883561 | Personal Protection Kit |
| 50749756883172 | LAP CHOLE PACK PGYBK |
| 00749756879149 | Hot / Cold Therapy Unit Combo |
| 00749756879132 | Hot / Cold Therapy Unit Combo |
| 50749756879120 | Cold Therapy Blanket |
| 00749756879118 | Cold Therapy Blanket |
| 50749756879106 | Cold Therapy Blanket |
| 00749756879095 | Cold Therapy Blanket |
| 50749756879083 | Cold Therapy Blanket |
| 00749756879033 | Cold Therapy Blanket |
| 50749756879014 | Cold Therapy Blanket |
| 00749756879002 | Cold Therapy Blanket |
| 50749756877249 | AntiFog Bulk Liquid |
| 50749756877058 | INTL-KFMMC CATH LAB PACK |
| 50749756877003 | Electrosurgical Pencil and Holster |
| 50749756876587 | Cold Therapy Blanket |
| 00749756876575 | JetStream Hot/Cold Therapy Unit |
| 00749756876568 | JetStream Hot/Cold Therapy Unit |
| 00749756876551 | JetStream Hot/Cold Therapy Unit |
| 00749756876544 | JetStream Hot/Cold Therapy Unit |
| 00749756876537 | JetStream Hot/Cold Therapy Unit |
| 00749756876520 | JetStream Hot/Cold Therapy Unit |
Trademark Results [DeRoyal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DEROYAL 97290594 not registered Live/Pending |
Men, Helei 2022-03-01 |
 DEROYAL 78141193 2829824 Live/Registered |
DeRoyal Industries, Inc. 2002-07-03 |
 DEROYAL 78141187 2829823 Live/Registered |
DeRoyal Industries, Inc. 2002-07-03 |
 DEROYAL 78141183 2741924 Live/Registered |
DeRoyal Industries, Inc. 2002-07-03 |
 DEROYAL 78141171 2727248 Live/Registered |
DeRoyal Industries, Inc. 2002-07-03 |
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