Labor Guard Perianal Stabilizer

GUDID 00855459008097

Stetrix, Inc.

Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00855459008097
• NIH Device Record Key: edb08f01-e590-4fff-861d-b0f46bf8e6e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Labor Guard Perianal Stabilizer
• Version Model Number: LG-01
• Company DUNS: 827509667
• Company Name: Stetrix, 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: 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	00855459008097 [Primary]
GS1	10855459008094 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN160005

FDA Product Code

• PNU: Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery

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: 2024-11-29
• Device Publish Date: 2024-11-21

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
• 00855459008097 - Labor Guard Perianal Stabilizer: 2024-11-29
• 00855459008097 - Labor Guard Perianal Stabilizer: 2024-11-29