Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Rectal dilator, reusable FDA UDI
- Device Name
- BUIE FISTULA PROBES. SILVER PROBE/STAINLESS STEEL HANDLE. OVERALL LENGTH 6-1/2" (16.5CM) LIGHT. FDA UDI
- Model / Reference
- 30-760 FDA UDI
- Description
- BUIE FISTULA PROBES. SILVER PROBE/STAINLESS STEEL HANDLE. OVERALL LENGTH 6-1/2" (16.5CM) LIGHT. FDA UDI
Identifiers
- Catalog Number
- 30-760 FDA UDI
- Primary DI / UDI-DI
- 00842180176027 FDA UDI
- FDA Product Code
- KOA FDA UDI
- GMDN Term
- Rectal dilator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 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
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rectal dilator, reusable
Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rectal dilator, reusable.
- Sohn's Dilators — TOOLS FOR SURGERY, LLC · 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 |
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Manufacturer
- Manufacturer
- Elmed Incorporated
Sources (1)
- FDA UDI bc0e61c9-e7e2-4cb3-a376-18ec4b23d108 35 fields · synced Jun 6, 2026