Karl Schumacher FOAM

GUDID 00842517100046

Resorbable Collagen Dental Wound Dressing

KARL SCHUMACHER DENTAL INSTRUMENT CO., INC.

General oral wound dressing, animal-derived

• Primary Device ID: 00842517100046
• NIH Device Record Key: 634ecc58-9071-41a5-8133-1763fc970e67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Karl Schumacher FOAM
• Version Model Number: RCWF0001
• Company DUNS: 043957315
• Company Name: KARL SCHUMACHER DENTAL INSTRUMENT CO., INC.
• Device Count: 10
• 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: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842517100039 [Unit of Use]
GS1	00842517100046 [Primary]

FDA Product Code

• KGN: Dressing, Wound, Collagen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-09-26

Devices Manufactured by KARL SCHUMACHER DENTAL INSTRUMENT CO., INC.

• 00842517102545 - Karl Schumacher: 2023-11-22 Sm Str Proximator, 2.5mm Wide Tip, Green
• 00842517102552 - Karl Schumacher: 2023-11-22 Lg Str Proximator, 4.5mm Wide Tip, Green
• 00842517102569 - Karl Schumacher: 2023-11-22 Sm Cvd Proximator, 2.5mm Wide Tip, Blue
• 00842517102576 - Karl Schumacher: 2023-11-22 Lg Cvd Proximator, 4.5mm Wide Tip, Blue
• 00842517102583 - Karl Schumacher: 2023-11-22 Spade Proximator, Yellow
• 00842517102590 - Karl Schumacher: 2023-11-22 Aetranox Spade Proximator, Yellow
• 00842517102613 - Karl Schumacher: 2023-11-22 Sm Distal Ang Proximator, 2.5mm, Purple
• 00842517102620 - Karl Schumacher: 2023-11-22 Sm Mesial Ang Proximator, 2.5mm, Purple