Kera S-Powder

GUDID EDWA1004000PK1

NPM - Cobalt-based dental sinter powder - 5 kg Canister

Eisenbacher Dentalwaren ED GmbH

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• Primary Device ID: EDWA1004000PK1
• NIH Device Record Key: 9b0e3a51-cefa-4aee-871f-54a6a1f38c9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kera S-Powder
• Version Model Number: 1004000PK
• Company DUNS: 344231006
• Company Name: Eisenbacher Dentalwaren ED GmbH
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDWA1004000PK1 [Primary]

FDA Product Code

• EJH: Alloy, Metal, Base

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-27
• Device Publish Date: 2020-07-17

On-Brand Devices [Kera S-Powder]

• EDWA1004000P1: NPM - Cobalt-based dental sinter powder
• EDWA1004000PK1: NPM - Cobalt-based dental sinter powder - 5 kg Canister