gudid
Primary ID: BYTERKS
Impression Rekit (Small) (UDI BYTERKS)
Manufactured by STRAIGHT SMILE LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Impression Rekit (Small) - Primary ID BYTERKS
Device Regulatory Overview
The Impression Rekit (Small) (Model/Catalog Number: BYTERKS) is a medical device manufactured by STRAIGHT SMILE LLC. This product is indexed under FDA Product Code / Category Classification ELW within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- BYTERKS
- Product Code / EMDN
- ELW
- Device Name
- Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit
- Database Sync Date
- 2026-08-09 09:37:45
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 Impression Rekit (Small)?
The registered manufacturer of record for Impression Rekit (Small) is STRAIGHT SMILE LLC.
What is the Primary UDI-DI identifier for Impression Rekit (Small)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is BYTERKS.
What classification code is assigned to this device?
This device is registered under product classification code ELW.
Similar Classification Devices (ELW)
Other Devices by STRAIGHT SMILE LLC
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint