Simelo

GUDID 06977153531016

WEIHAI XINGTAI PACKAGING PRODUCTS CO.,LTD.

Chemical/physical sterilization process indicator

• Primary Device ID: 06977153531016
• NIH Device Record Key: 8165735b-fdaf-4e51-a0d6-39ab8a7cf284
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simelo
• Version Model Number: 50mm×200m
• Company DUNS: 541834823
• Company Name: WEIHAI XINGTAI PACKAGING PRODUCTS CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	06977153531016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193561

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: 2024-09-20
• Device Publish Date: 2024-09-12

On-Brand Devices [Simelo]

• 06977153532112: 190mm×330mm
• 06977153532051: 90mm×260mm
• 06977153532020: 70mm×230mm
• 06977153532013: 57mm×130mm
• 06977153531016: 50mm×200m
• 06977153530026: 133m×279mm
• 06977153530019: 133mm×191mm
• 06977153530002: 83mm×165mm