Identity
- Trade Name
- Millennium FDA UDI
- Generic Name
- Colorectal sizer FDA UDI
- Device Name
- Stainless Steel, Bowel Sizer, 28mm Barrel Base FDA UDI
- Model / Reference
- 72-52002928 FDA UDI
- Description
- Stainless Steel, Bowel Sizer, 28mm Barrel Base FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776406981 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Colorectal sizer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Colorectal sizer
Millennium by AVALIGN TECHNOLOGIES, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Colorectal sizer.
- ELMED — ELMED INCORPORATED · Class I
- EEA — Covidien LP · Class I
- Circular Stapler Head Sizer Set — TOOLS FOR SURGERY, LLC · Class I
- ELMED — ELMED INCORPORATED · Class I
- ELMED — ELMED INCORPORATED · Class I
- Circular Stapler Anvil Sizer Set — TOOLS FOR SURGERY, LLC · Class I
- ELMED — ELMED INCORPORATED · Class I
- ELMED — ELMED INCORPORATED · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AVALIGN TECHNOLOGIES, Inc.
Sources (1)
- FDA UDI e53c51ed-aab3-4401-8d09-1ce8086473f1 34 fields · synced May 31, 2026