Tyvek® Roll with STERRAD™ Chemical Indicator 250 mm x 70 m (10" x 76 yds.) (UDI 10705037015832)
Manufactured by Advanced Sterilization Products, Inc.
Device Regulatory Overview
The Tyvek® Roll with STERRAD™ Chemical Indicator 250 mm x 70 m (10" x 76 yds.) (Model/Catalog Number: 12425) is a medical device manufactured by Advanced Sterilization Products, Inc.. This product is indexed under FDA Product Code / Category Classification S01010201 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 12425
- Product Code / EMDN
- S01010201
- Device Name
- Tyvek® Pouches and Rolls with STERRAD™ Chemical Indicator
- Database Sync Date
- 2026-08-09 16:30:20
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Tyvek® Roll with STERRAD™ Chemical Indicator 250 mm x 70 m (10" x 76 yds.)?
The registered manufacturer of record for Tyvek® Roll with STERRAD™ Chemical Indicator 250 mm x 70 m (10" x 76 yds.) is Advanced Sterilization Products, Inc..
What is the Primary UDI-DI identifier for Tyvek® Roll with STERRAD™ Chemical Indicator 250 mm x 70 m (10" x 76 yds.)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10705037015832.
What classification code is assigned to this device?
This device is registered under product classification code S01010201.
Similar Classification Devices (S01010201)
Other Devices by Advanced Sterilization Products, Inc.
- → Aptimax™ Instrument Tray 380 mm x 250 mm x 30 mm (15 in x 10 in x 1.2 in)
- → Tyvek® Self Seal Pouch with STERRAD™ Chemical Indicator 250 mm x 480 mm (10" x 19")
- → Aptimax™ Instrument Tray 380 mm x 150 mm x 30 mm (15 in x 6 in x 1.2 in)
- → Tyvek® Roll with STERRAD™ Chemical Indicator 500 mm x 70 m (20" x 76 yds.)
Programmatic Export
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JSON API Endpoint