Panni Retractor System

GUDID 10855459008087

Stetrix, Inc.

Limb/torso/head restraint, single-use

• Primary Device ID: 10855459008087
• NIH Device Record Key: f2f7b148-006a-4a58-bb44-0449d7395db1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panni Retractor System
• Version Model Number: PPR-13
• Company DUNS: 827509667
• Company Name: Stetrix, 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855459008080 [Primary]
GS1	10855459008087 [Package]; Contains: 00855459008080; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• HXT: Tape, Orthopedic

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: 2025-01-20
• Device Publish Date: 2025-01-10

Devices Manufactured by Stetrix, Inc.

• 00855459008004 - Pannus Retention System: 2025-01-20
• 10855459008049 - Pannus Retention System: 2025-01-20
• 10855459008056 - Pannus Retention System: 2025-01-20
• 10855459008087 - Panni Retractor System: 2025-01-20
• 10855459008087 - Panni Retractor System: 2025-01-20
• 00855459008097 - Labor Guard Perianal Stabilizer: 2024-11-29