Pentax of America

GUDID 04961333248117

Capture Module

PENTAX OF AMERICA, INC.

Soluble tumour necrosis factor receptor 1 (sTNFR1) IVD, control

• Primary Device ID: 04961333248117
• NIH Device Record Key: c39e1010-d1a2-45c4-b545-cf187a081f8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pentax of America
• Version Model Number: 9380
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, INC.
• 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: true
• Single Use: false
• Lot Batch: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333248117 [Primary]

FDA Product Code

• OUG: Medical Device Data System

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: 2022-11-14
• Device Publish Date: 2022-11-04

Devices Manufactured by PENTAX OF AMERICA, INC.

• 00854924006255 - C2 CryoBalloon Ablation System: 2025-04-14 Gen 2 360 Degree Pear Catheter
• 00854924006293 - C2 CryoBalloon Ablation System: 2025-04-14 Gen 2 360 Degree Standard Catheter
• 04961333255313 - C2 CryoBalloon: 2024-09-20
• 04961333255320 - C2 CryoBalloon: 2024-09-20
• 04961333254309 - MULTI-SPEECH: 2023-09-04 Multi-Speech Microphone, Condensor
• 04961333248117 - Pentax of America: 2022-11-14Capture Module
• 04961333248117 - Pentax of America: 2022-11-14 Capture Module
• 04961333248445 - C2 CryoBalloon Nitroclip: 2020-08-17 NitroClip
• 00854924006408 - C2 CryoBalloon EndoGrip: 2020-08-06 EndoGrip