Burnshield 901007

GUDID 16007645001400

BURNSHIELD 60X40CM DRESSINGS

BURNSHIELD (PTY) LTD

Synthetic polymer burn dressing, gel-coated

• Primary Device ID: 16007645001400
• NIH Device Record Key: c00b3706-abe0-4de7-a203-151bf0d30a15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Burnshield
• Version Model Number: 901007
• Catalog Number: 901007
• Company DUNS: 635842958
• Company Name: BURNSHIELD (PTY) LTD
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +27114405171
• Email: sales@burnshield.com
• Phone: +27114405171
• Email: sales@burnshield.com
• Phone: +27114405171
• Email: sales@burnshield.com
• Phone: +27114405171
• Email: sales@burnshield.com
• Phone: +27114405171
• Email: sales@burnshield.com
• Phone: +27114405171
• Email: sales@burnshield.com
• Phone: +27114405171
• Email: sales@burnshield.com
• Phone: +27114405171
• Email: sales@burnshield.com
• Phone: +27114405171
• Email: sales@burnshield.com
• Phone: +27114405171
• Email: sales@burnshield.com

Device Dimensions

• Weight: 500 Gram
• Width: 400 Millimeter
• Length: 600 Millimeter
• Weight: 500 Gram
• Width: 400 Millimeter
• Length: 600 Millimeter
• Weight: 500 Gram
• Width: 400 Millimeter
• Length: 600 Millimeter
• Weight: 500 Gram
• Width: 400 Millimeter
• Length: 600 Millimeter
• Weight: 500 Gram
• Width: 400 Millimeter
• Length: 600 Millimeter
• Weight: 500 Gram
• Width: 400 Millimeter
• Length: 600 Millimeter
• Weight: 500 Gram
• Width: 400 Millimeter
• Length: 600 Millimeter
• Weight: 500 Gram
• Width: 400 Millimeter
• Length: 600 Millimeter
• Weight: 500 Gram
• Width: 400 Millimeter
• Length: 600 Millimeter
• Weight: 500 Gram
• Width: 400 Millimeter
• Length: 600 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06007645001403 [Primary]
GS1	16007645001400 [Package]; Contains: 06007645001403; Package: BOX [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943728

FDA Product Code

• MGQ: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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: 2019-01-17
• Device Publish Date: 2018-12-17

On-Brand Devices [Burnshield]

• 06007645007917: BURNSHIELD BLANK WOOL 1.6x1.8m(64X71")
• 16007645007679: BURNSHIELD CONTOUR KIT DOUBLE
• 16007645007662: BURNSHIELD CONTOUR KIT SINGLE
• 26007645006358: MUNDIAL HOME/TRAVEL KIT
• 16007645006054: BURNSHIELD BURN BLOTTS 0.9G
• 16007645006047: BURNSHIELD HYDROGEL 50ML SPRAY
• 16007645003954: BURNSHIELD 60X40CM FACEMASK
• 06007645003537: BURNSHIELD CONTOUR 1X2M
• 16007645003527: BURNSHIELD CONTOUR 1X1M
• 06007645002073: BURNSHIELD TWIN BLANKET 1.2X1.6M
• 26007645001452: BURNSHIELD 20X45CM FACEMASK
• 26007645001414: BURNSHIELD DRESS 20x45cm (8x18")
• 16007645001400: BURNSHIELD 60X40CM DRESSINGS
• 06007645001397: BURNSHIELD 20X20CM DRESSINGS
• 96007645001383: BURNSHIELD 10X10CM DRESSINGS IN BULK
• 16007645000212: BURNSHIELD BURN BLOTTS 3.5ML
• 36007645000193: BURNSHIELD HYD SPRAY BOTTLE 125ML(4.5oz)
• 06007645000222: BURNSHIELD BLANK WOOL 1.2x1.6m(48x64")
• 16007645007655: BURNSHIELD DRESS CONTOUR 1X2M(40X80 )BAG
• 16007645007648: BURNSHIELD DRESS CONTOUR 1X1M(40X40 )BAG
• 36007645005303: BURNSHIELD HYDROGEL TUBE 25ML (0.85 OZ)
• 26007645004590: BURNSHIELD HYDROGEL TUBE 10ML (0.35 OZ)
• 36007645001541: BURNSHIELD MINI BURN KIT
• 06007645000161: BURNSHIELD BLANK WOOL 2.45mx1.6m(98"X64")
• 16007645001431: BURNSHIELD DRESSING 25MMX0.50M (1X20") DIGIT
• 16007645004302: BURNSHIELD HYDROGEL SPRAY BOTTLE 75ML (2.70oz)
• 16007645006344: MUNDIAL DRESSING 10CMX10CM (4X4") (2'S)
• 16007645006337: MUNDIAL BURN KIT
• 16007645005804: BURNSHIELD ESSENTIAL BURN KIT LARGE
• 16007645001424: BURNSHIELD DRESSING 50MMX1M (2X40") LIMB
• 16007645000120: BURNSHIELD HYDROGEL BOTTLE 50ML (1.8OZ)
• 16007645007921: BURNSHIELD EMERGENCY KIT IN NYLON BAG
• 16007645002001: BURNSHIELD CATER KIT
• 16007645005781: BURNSHIELD ESSENTIAL BURN KIT SMALL