AQUACEL AG BURN 403791

GUDID 00768455124176

AQUACEL AG BURN GLOVE SZ1 (1X1PK) US

CONVATEC, PURCHASING DEPARTMENT

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial, sterile Exudate-absorbent dressing, hydrophilic-gel, antimicrobial, sterile Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 00768455124176
• NIH Device Record Key: 8d261e97-9d73-4544-8a90-9c4bd3e96fbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQUACEL AG BURN
• Version Model Number: 403791
• Catalog Number: 403791
• Company DUNS: 809784593
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00768455110667 [Package]; Package: Carton [1 Units]; In Commercial Distribution
GS1	00768455124176 [Primary]
GS1	10768455110664 [Package]; Contains: 00768455110667; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090254

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: 2016-08-22

On-Brand Devices [AQUACEL AG BURN]

• 00768455124251: AQUACEL AG BURN GLOVE SZ4 (1X1PK) US
• 00768455124244: AQUACEL AG BURN GLOVE SZ3 (1X1PK) US
• 00768455124237: AQUACEL AG BURN GLOVE SZ2 (1X1PK) US
• 00768455124176: AQUACEL AG BURN GLOVE SZ1 (1X1PK) US
• 00768455124169: AQUACEL AG BURN DRS FLT 54X45CM(1X3)US
• 00768455124152: AQUACEL AG BURN DRS FLT 23X100CM(1X3)US
• 00768455124145: AQUACEL AG BURN DRS FLT 23X30CM(1X5)US
• 00768455124138: AQUACEL AG BURN DRS FLT 17X15CM