SIGMA

GUDID 04717048508479

SIGMA MEDICAL SUPPLIES CORP.

Sterilization packaging, single-use

• Primary Device ID: 04717048508479
• NIH Device Record Key: 78e9decd-418d-495b-b0d6-4b918f88319e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGMA
• Version Model Number: SMSE057133
• Company DUNS: 656054251
• Company Name: SIGMA MEDICAL SUPPLIES CORP.
• 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: true
• Expiration Date: true
• 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	04717048508479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202462

FDA Product Code

• FRG: Wrap, Sterilization

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: 2023-09-12
• Device Publish Date: 2023-09-04