Atrauman Ag

Basic Information

• Brand Name: Atrauman Ag
• Primary DI: 04052199732404
• Version / Model: 499606 Atrauman Ag USA st 5x5cm, P10
• Catalog Number: 499606
• Company Name: PAUL HARTMANN AG
• Labeler DUNS: 315768788
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-19
• Public Version: 2
• Public Version Date: 2025-07-03
• Public Version Status: Update
• Public Device Record Key: 48efebe2-35df-41b4-a644-f25e18f5e2cb

Device Description

Atrauman Ag USA st 5x5cm, P10

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
46855	Wound-nonadherent dressing, permeable, non-antimicrobial	A wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04052199732404	GS1
Package	04052199732411	GS1	FBX	10	In Commercial Distribution
Package	04052199732428	GS1	Case	12	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K242758	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius