Cerdak

GUDID 18903389005248

Cerdak Aerocloth 100 x 250 mm

CARBORUNDUM UNIVERSAL LIMITED

Wound-nonadherent dressing, absorbent, sterile

• Primary Device ID: 18903389005248
• NIH Device Record Key: aac8ddb7-d7be-4b4b-bdff-87f5a7d934cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cerdak
• Version Model Number: Cerdak Aerocloth
• Company DUNS: 650051832
• Company Name: CARBORUNDUM UNIVERSAL LIMITED
• Device Count: 10
• 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: true
• 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: 3013255574
• Email: bupet2015@gmail.com
• Phone: 3013255574
• Email: bupet2015@gmail.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE IN ANY AMBIENT TEMPERATURE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE IN ANY AMBIENT TEMPERATURE

Device Identifiers

Device Issuing Agency	Device ID
GS1	18903389005248 [Package]; Contains: 58903389005246; Package: [10 Units]; In Commercial Distribution
GS1	28903389005245 [Unit of Use]
GS1	58903389005246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153138

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-18

On-Brand Devices [Cerdak]

• 18903389005323: Cerdak Drydoc 15 x 25 mm
• 18903389005316: Cerdak Aerofilm 45 x 300 mm
• 18903389005309: Cerdak Aerofilm 45 x 200 mm
• 18903389005293: Cerdak Aerofilm 45 x 150 mm
• 18903389005286: Cerdak Aerofilm 50 x 100 mm
• 18903389005279: Cerdak Aerofilm 50 X 50 mm
• 18903389005262: Cerdak Aerofilm 50 x 25 mm
• 18903389005255: Cerdak Aerofilm 30 x 30 mm
• 18903389005248: Cerdak Aerocloth 100 x 250 mm
• 18903389005224: Cerdak Aerocloth 80 x 150 mm
• 18903389005217: Cerdak Aerocloth 60 x 83 mm
• 18903389005200: Cerdak Aerocloth 45 x 300 mm
• 18903389005194: Cerdak Aerocloth 45 x 200 mm
• 18903389005187: Cerdak Aerocloth 45 x 150 mm
• 18903389005170: Cerdak Aerocloth 50 X 100 mm
• 18903389005163: Cerdak Aerocloth 50 x 50 mm
• 18903389005156: Cerdak Aerocloth 50 x 25 mm
• 18903389005149: Cerdak Aerocloth 30X30 mm
• 18903389005132: Cerdak Basic 100 x 250 mm
• 18903389005125: Cerdak Basic 100 x 200 mm
• 18903389005118: Cerdak Basic 80 x150mm
• 18903389005101: Cerdak Basic 60 x 83mm
• 18903389005095: Cerdak Basic 100x150mm
• 18903389005088: Cerdak Basic 100x100mm
• 18903389005071: Cerdak Basic 45x300mm
• 18903389005064: Cerdak Basic 45x200mm
• 18903389005057: Cerdak Basic 45x150mm
• 18903389005040: Cerdak Basic 50x100mm
• 18903389005033: Cerdak Basic 50x50mm
• 18903389005026: Cerdak Basic 50x25mm
• 58903389005017: Cerdak Basic 30x30mm