Dukal 350-10

GUDID 50665973003387

Non-Skid Shoe Covers

Dukal LLC

Shoe cover

• Primary Device ID: 50665973003387
• NIH Device Record Key: cf3b0e0b-4e70-4936-a6dd-2113d0b9646d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dukal
• Version Model Number: 350-10
• Catalog Number: 350-10
• Company DUNS: 791014871
• Company Name: Dukal LLC
• Device Count: 100
• 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: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00665973003375 [Unit of Use]
GS1	50665973003387 [Package]; Contains: 60665973003377; Package: Case [10 Units]; In Commercial Distribution
GS1	60665973003377 [Primary]

FDA Product Code

• FXP: COVER, SHOE, OPERATING-ROOM

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-14
• Device Publish Date: 2022-12-06

On-Brand Devices [Dukal]

• 20665973029126: Surgical Mask, Level 3, Blue Earloop, Non-Sterile
• 20665973029027: Premium Soft Cloth Tape, 6" x 10yds
• 20665973029010: Premium Soft Cloth Tape, 4" x 10yds
• 20665973029003: Premium Soft Cloth Tape, 2" x 10yds
• 00665973028996: Premium Soft ClothTape, 1" x 10yds
• 20665973003164: Isolation Gown, Universal, Blue
• 50665973003387: Non-Skid Shoe Covers
• 00665973025070: Alcohol Prep Pad, Medium, Sterile
• 30665973001754: Bouffant Cap 24"
• 30665973001747: Bouffant Cap 21", Blue
• 00665973027227: Barrier Film, 4"x6" sheets, Blue
• 00665973027210: Barrier Film, 4"x6" sheets, Clear
• 10665973015481: Cotton Tip Applicators 6", Sterile
• 00665973007557: Cloth Athletic Tape 3"x10yd
• 10665973001576: Cotton Tip Applicators 3", Sterile
• 00665973027753: Face Shield
• 00665973027715: Protective Coverall with Hood, XXL
• 00665973027708: Protective Coverall with Hood, XXL
• 00665973027692: Protective Coverall with Hood, XL
• 00665973027333: Headrest Cover, 10" x 13"
• 00665973027326: Headrest Cover, 10" x 10"
• 00665973026671: Neuro Sponge 3", Non Sterile
• 00665973005409: ABD Roll 8" x 20 yd, Non-Sterile
• 00665973004839: Fluff Bandage Roll 4.5" x 147" 6-Ply, Non-Sterile
• 00665973001555: Gauze Packing Roll 1/2" x 100 yd 4-Ply
• 30665973001457: Prep Sponges 1.5"
• 30665973001440: Prep Sponges 1.25"
• 00665973001203: Gauze Packing Roll 1" x 100 yd 4-Ply
• 00665973001197: Gauze Packing Roll 2" x 100 yd 4-Ply
• 25665973010365: Gauze Sponges 3" x 3" 12-Ply, Non-Sterile
• 25665973010136: Gauze Sponges 4" x 4" 8-Ply, Non-Sterile
• 22665973010368: Gauze Sponges 3" X 3" 12-Ply, Non-Sterile
• 30665973028980: Premium Split Sponge
• 20665973028631: Boot Covers
• 20665973028624: Poly-Coated Chemotherapy Gown, XXL
• 20665973028617: Poly-Coated Chemotherapy Gown, XL
• 20665973028600: Poly-Coated Chemotherapy Gown, L
• 20665973028594: Poly-Coated Chemotherapy Gown, M
• 20665973027627: Multi-Layer Isolation Gown, Universal, Yellow
• 20665973028419: Level 2 Isolation Gown, XXL, Yellow
• 20665973028402: Beard Covers
• 20665973028396: Level 2 Poly Coated Isolation Gown, XL, Yellow
• 20665973028389: Level 2 Poly Coated Isolation Gown, Universal, Blue
• 20665973028372: Level 2 Poly Coated Isolation Gown, Universal, Yellow
• 20665973028365: Isolation Gown, XXL, Yellow
• 20665973028358: Level 2 Isolation Gown, XL, Yellow
• 20665973028341: Level 2 Isolation Gown, Universal, Yellow
• 20665973028334: Level 2 Isolation Gown, XL, Yellow
• 20665973028327: Level 2 Isolation Gown, Universal, Yellow
• 20665973028303: Multi-Layer Isolation Gown, Universal, Yellow