DeRoyal 46-612

GUDID 30749756912113

Xeroform Roll

DEROYAL INDUSTRIES, INC.

Wound-nonadherent dressing, permeable, antimicrobial

• Primary Device ID: 30749756912113
• NIH Device Record Key: 1dfb7b61-e9b5-4973-9416-0df57d2a4b71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DeRoyal
• Version Model Number: 46-612
• Catalog Number: 46-612
• Company DUNS: 096372255
• Company Name: DEROYAL INDUSTRIES, INC.
• Device Count: 1
• 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00749756912112 [Primary]
GS1	30749756912113 [Package]; Contains: 00749756912112; Package: BX [6 Units]; In Commercial Distribution
GS1	50749756912117 [Package]; Package: CA [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093349

FDA Product Code

• FRO: Dressing, wound, drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-10
• Device Publish Date: 2023-02-02

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