ZENEX MULTI Fixture Set

GUDID 08800070230299

Izenimplant Co., Ltd.

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• Primary Device ID: 08800070230299
• NIH Device Record Key: 4b4da030-301e-4568-8dbc-e21a2a2699f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZENEX MULTI Fixture Set
• Version Model Number: ZMSW5506S
• Company DUNS: 694625347
• Company Name: Izenimplant Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800070230299 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233163

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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: 2024-01-03
• Device Publish Date: 2023-12-26

On-Brand Devices [ZENEX MULTI Fixture Set]

• 08800070229361: ZMSM3511S
• 08800070229354: ZMSM3510S
• 08800070229347: ZMSM3508S
• 08800070228371: ZMSW5011S
• 08800070228364: ZMSW5010S
• 08800070228357: ZMSW5008S
• 08800070228340: ZMSW5007S
• 08800070228319: ZMSR4515S
• 08800070228302: ZMSR4513S
• 08800070228296: ZMSR4511S
• 08800070228289: ZMSR4510S
• 08800070228272: ZMSR4508S
• 08800070228265: ZMSR4507S
• 08800070228234: ZMSR4015S
• 08800070228227: ZMSR4013S
• 08800070228210: ZMSR4011S
• 08800070228203: ZMSR4010S
• 08800070228197: ZMSR4008S
• 08800070228180: ZMSR4007S
• 08800070228173: ZMSM3515S
• 08800070228166: ZMSM3513S
• 08800070228944: ZMTW7013S
• 08800070228937: ZMTW7011S
• 08800070228920: ZMTW7010S
• 08800070228913: ZMTW7008S
• 08800070228906: ZMTW7007S
• 08800070228890: ZMTW6013S
• 08800070228883: ZMTW6011S
• 08800070228876: ZMTW6010S
• 08800070228869: ZMTW6008S
• 08800070228852: ZMTW6007S
• 08800070228838: ZMTW5513S
• 08800070228821: ZMTW5511S
• 08800070228814: ZMTW5510S
• 08800070228807: ZMTW5508S
• 08800070228791: ZMTW5507S
• 08800070228784: ZMTW5015S
• 08800070228777: ZMTW5013S
• 08800070228760: ZMTW5011S
• 08800070228753: ZMTW5010S
• 08800070228746: ZMTW5008S
• 08800070228739: ZMTW5007S
• 08800070228722: ZMTR4515S
• 08800070228715: ZMTR4513S
• 08800070228708: ZMTR4511S
• 08800070228692: ZMTR4510S
• 08800070228685: ZMTR4508S
• 08800070228678: ZMTR4507S
• 08800070228661: ZMTR4015S
• 08800070228654: ZMTR4013S