ET PICK-UP GUIDE PIN

GUDID 00810125994937

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00810125994937
• NIH Device Record Key: b85b9824-f041-4840-a3d3-8605ac4f2c8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET PICK-UP GUIDE PIN
• Version Model Number: ETPGPM100LC
• Company DUNS: 796083090
• Company Name: HIOSSEN, 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: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00810125994937 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222636

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

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: 2024-07-15
• Device Publish Date: 2024-07-06

On-Brand Devices [ET PICK-UP GUIDE PIN]

• 00814913025728: ETFPG10SL
• 00814913025711: ETFPG05SL
• 00814913025704: ETFPG05S
• 00814913025698: ETFPG00SL
• 00814913025681: ETFPG00S
• 00814913025674: ETFPG10ML
• 00814913025667: ETFPG05ML
• 00814913025650: ETFPG05M
• 00814913025643: ETFPG00ML
• 00814913025636: ETFPG00M
• 00810125995019: ETPGPR200LC
• 00810125995002: ETPGPR150LC
• 00810125994999: ETPGPR150C
• 00810125994982: ETPGPR100LC
• 00810125994975: ETPGPR100C
• 00810125994968: ETPGPM200LC
• 00810125994951: ETPGPM150LC
• 00810125994944: ETPGPM150C
• 00810125994937: ETPGPM100LC
• 00810125994920: ETPGPM100C