Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Myoma screw, reusable FDA UDI
- Device Name
- 5 MM DIA., 33 CM, MYOMA DRILL FDA UDI
- Model / Reference
- 52505-98 FDA UDI
- Description
- 5 MM DIA., 33 CM, MYOMA DRILL FDA UDI
Identifiers
- Catalog Number
- 52505-98 FDA UDI
- Primary DI / UDI-DI
- 00842180136885 FDA UDI
- 510(k) Number
- K181173 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Myoma screw, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
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: Myoma screw, reusable
Elmed by Elmed Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Myoma screw, reusable.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
- Pilling — AVALIGN TECHNOLOGIES, Inc. · Class II
- Quinelato — Schobell Industrial Ltda · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Gimmi — Gimmi GmbH · Class I
- Symmetry Surgical — SYMMETRY SURGICAL INC. · Class II
Cleared under the same submission
K181173 also covers:
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
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 II | Pending data |
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Manufacturer
- Manufacturer
- Elmed Incorporated
Sources (1)
- FDA UDI 38b306c1-9f88-48aa-8b53-bf5ce319b133 36 fields · synced Jun 1, 2026