Steri-Pocket

GUDID 00850071154016

Hanes Companies, Inc.

Surgical instrument guard, single-use

• Primary Device ID: 00850071154016
• NIH Device Record Key: e2b6f07f-918f-4493-8122-8a90bbbdcbfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Steri-Pocket
• Version Model Number: SP102
• Company DUNS: 139362420
• Company Name: Hanes Companies, Inc.
• Device Count: 100
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850071154016 [Primary]
GS1	00850071154047 [Unit of Use]

FDA Product Code

• MDM: Instrument, Manual, Surgical, General Use

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: 2025-02-14
• Device Publish Date: 2025-02-06

On-Brand Devices [Steri-Pocket]

• 00850071154023: SP300
• 00850071154016: SP102
• 00850071154054: SP100