SORBALUX ABD PAD ST 3x5 400/CS

GUDID 04052199583594

SORBALUX ABD PAD ST 3x5 400/CS

HARTMANN USA, INC.

Non-woven gauze pad

• Primary Device ID: 04052199583594
• NIH Device Record Key: bf18b22e-637c-4344-a91b-5e3e0066e294
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SORBALUX ABD PAD ST 3x5 400/CS
• Version Model Number: 15700004
• Company DUNS: 010137511
• Company Name: HARTMANN USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052199583587 [Primary]
GS1	04052199583594 [Package]; Contains: 04052199583587; Package: [25 Units]; In Commercial Distribution
GS1	04052199583600 [Package]; Package: [16 Units]; In Commercial Distribution

FDA Product Code

• NAB: Gauze / Sponge,Nonresorbable For External Use

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: 2021-12-30
• Device Publish Date: 2021-12-22

Devices Manufactured by HARTMANN USA, INC.

• 30612553024276 - ColActive Plus 2x2: 2024-05-14 ColActive Plus 2x2
• 30612553024283 - ColActive Plus 4x4: 2024-05-14 ColActive Plus 4x4
• 20612553024293 - COLACTIVE PLUS 7x7 10/BX: 2024-05-14 COLACTIVE PLUS 7x7 10/BX
• 30612553024306 - ColActive Plus AG 2x2 600/cs: 2024-05-14 ColActive Plus AG 2x2 600/cs
• 30612553024313 - ColActive Plus AG 4x4 300/cs: 2024-05-14 ColActive Plus AG 4x4 300/cs
• 30612553024320 - COLACTIVE PLUS AG 7x7 10/BX: 2024-05-14 COLACTIVE PLUS AG 7x7 10/BX
• 00612553000019 - CollaSorb 1g Powder: 2024-03-28 CollaSorb Powder Collagen Wound Filler
• 10612553024395 - AC-TAPE PLUS: 2024-01-24 AC-TAPE PLUS 3X5 48/CS