AVALON BIOMED

GUDID 06975718050361

SHENZHEN DENCO MEDICAL CO., LTD

Manual endodontic file/rasp, single-use

• Primary Device ID: 06975718050361
• NIH Device Record Key: 3c0a7cc9-1afe-4ef7-b529-668f3d761b4b
• Commercial Distribution Discontinuation: 2023-08-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AVALON BIOMED
• Version Model Number: SlimShaper sterie 25mm ZS3
• Company DUNS: 543035008
• Company Name: SHENZHEN DENCO MEDICAL CO., LTD
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975718050361 [Primary]

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

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

[06975718050361]

Radiation Sterilization

[06975718050361]

Radiation Sterilization

[06975718050361]

Radiation Sterilization

[06975718050361]

Radiation Sterilization

[06975718050361]

Radiation Sterilization

[06975718050361]

Radiation Sterilization

[06975718050361]

Radiation Sterilization

[06975718050361]

Radiation Sterilization

[06975718050361]

Radiation Sterilization

[06975718050361]

Radiation Sterilization

[06975718050361]

Radiation Sterilization

[06975718050361]

Radiation Sterilization

[06975718050361]

Radiation Sterilization

[06975718050361]

Radiation Sterilization

[06975718050361]

Radiation Sterilization

[06975718050361]

Radiation Sterilization

[06975718050361]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-16
• Device Publish Date: 2023-08-08

On-Brand Devices [AVALON BIOMED]

• 06975718050620: ApicalShaper sterile 25mm Z35/03
• 06975718050606: ApicalShaper sterile 31mm Z30/03
• 06975718050590: ApicalShaper sterile 25mm Z30/03
• 06975718050583: ApicalShaper sterile 21mm Z30/03
• 06975718050521: Excalibur sterile 25mm E45
• 06975718050514: Excalibur sterile 21mm E45
• 06975718050491: Excalibur sterile 25mm E35
• 06975718050484: Excalibur sterile 21mm E35
• 06975718050453: Excalibur sterile 21mm E25
• 06975718050361: SlimShaper sterie 25mm ZS3
• 06975718050354: SlimShaper sterie 25mm ZS2
• 06975718050347: SlimShaper sterie 25mm ZS1
• 06975718050323: SlimShaper sterile 21mm ZS3
• 06975718050316: SlimShaper sterile 21mm ZS2
• 06975718050309: SlimShaper sterile 21mm ZS1
• 06975718050293: SlimShaper sterile 21mm ZS1-ZS3
• 06975718050149: BlueShaper sterile 25mm Z1
• 06975718050057: BlueShaper sterile 21mm ZX-Z5
• 06975718050040: BlueShaper sterile 19mm ZX