Atrauman Ag 499607

GUDID 04052199732442

Atrauman Ag USA st 10x10cm, P10

PAUL HARTMANN AG

Wound-nonadherent dressing, permeable, non-antimicrobial

• Primary Device ID: 04052199732442
• NIH Device Record Key: 2bd00c33-1ab5-45cc-87d4-d38cdefbbcd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atrauman Ag
• Version Model Number: 499607 Atrauman Ag USA st 10x10cm, P10
• Catalog Number: 499607
• Company DUNS: 315768788
• Company Name: PAUL HARTMANN AG
• 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: true
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052199732435 [Primary]
GS1	04052199732442 [Package]; Contains: 04052199732435; Package: FBX [10 Units]; In Commercial Distribution
GS1	04052199732459 [Package]; Package: CS [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242758

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: 2025-03-27
• Device Publish Date: 2025-03-19

On-Brand Devices [Atrauman Ag]

• 04052199732473: Atrauman Ag USA st 10x20cm, P10
• 04052199732442: Atrauman Ag USA st 10x10cm, P10
• 04052199732404: Atrauman Ag USA st 5x5cm, P10