GeneraBloc Endoscopy Bite Block GIS-3-S

GUDID 10893029002547

Endoscopy Bite Block

GI Supply, Inc.

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• Primary Device ID: 10893029002547
• NIH Device Record Key: 1fbc42a8-29c9-447b-b5f5-de9ed1a85a8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GeneraBloc Endoscopy Bite Block
• Version Model Number: GIS-3
• Catalog Number: GIS-3-S
• Company DUNS: 160990313
• Company Name: GI Supply, Inc.
• Device Count: 1
• 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: true
• 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
GS1	00893029002540 [Primary]
GS1	10893029002547 [Package]; Contains: 00893029002540; Package: Master [100 Units]; In Commercial Distribution
GS1	20893029002544 [Package]; Contains: 00893029002540; Package: Dispenser [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K931044

FDA Product Code

• MNK: Endoscopic Bite Block

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: 2021-07-15
• Device Publish Date: 2021-07-07

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