gudid
Primary ID: R09971
REMEL (UDI R09971)
Manufactured by REMEL, INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for REMEL - Primary ID R09971
Device Regulatory Overview
The REMEL (Model/Catalog Number: R09971) is a medical device manufactured by REMEL, INC.. This product is indexed under FDA Product Code / Category Classification LIB within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- R09971
- Product Code / EMDN
- LIB
- Device Name
- Inoculum Water (25ml) 20/PK
- Database Sync Date
- 2026-08-09 09:35:51
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of REMEL?
The registered manufacturer of record for REMEL is REMEL, INC..
What is the Primary UDI-DI identifier for REMEL?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is R09971.
What classification code is assigned to this device?
This device is registered under product classification code LIB.
Similar Classification Devices (LIB)
Other Devices by REMEL, INC.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint