STERILUX AMD ST BULKY GZ 4.5x4.1YD 6P

GUDID 04052199500492

STERILUX AMD ST BULKY GZ 4.5x4.1YD 6P

PAUL HARTMANN AG

Wound-nonadherent dressing, permeable, antimicrobial

• Primary Device ID: 04052199500492
• NIH Device Record Key: 8bf3fbe0-682b-448a-90cd-b5b05d7ab87a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERILUX AMD ST BULKY GZ 4.5x4.1YD 6P
• Version Model Number: 15713135
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052199500485 [Primary]
GS1	04052199500492 [Package]; Contains: 04052199500485; Package: [120 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181315

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: 2020-09-09
• Device Publish Date: 2020-09-01

Devices Manufactured by PAUL HARTMANN AG

• 20612553013440 - AC TAPE PLUS 2X5 72/CS: 2024-01-24 AC TAPE PLUS 2X5 72/CS
• 04052199571331 - Hydrofilm 6x7cm sterile New P100: 2023-05-25 Hydrofilm 6x7cm sterile New P100
• 04052199571393 - Hydrofilm 6x7cm sterile P10: 2023-05-25 Hydrofilm 6x7cm sterile P10
• 04052199571423 - Hydrofilm 15x20cm sterile P50: 2023-05-25 Hydrofilm 15x20cm sterile P50
• 04052199571461 - Hydrofilm 20x30cm sterile P10: 2023-05-25 Hydrofilm 20x30cm sterile P10
• 04052199571508 - Hydrofilm 10x15cm sterile P50: 2023-05-25 Hydrofilm 10x15cm sterile P50
• 04052199571546 - Hydrofilm 10x12,5cm sterile P100: 2023-05-25 Hydrofilm 10x12,5cm sterile P100
• 04052199571577 - Hydrofilm 10x12,5cm sterile P10: 2023-05-25 Hydrofilm 10x12,5cm sterile P10