Identity
- Trade Name
- ARMSTRONG X VENT TUBE FDA UDI
- Generic Name
- Tympanostomy tube FDA UDI
- Device Name
- ARMSTRONG X BEVELED GROMMET 1.14MM ID BLUE FLUOROPLASTIC 5 PACK FDA UDI
- Model / Reference
- 525-201 FDA UDI
- Description
- ARMSTRONG X BEVELED GROMMET 1.14MM ID BLUE FLUOROPLASTIC 5 PACK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844505008495 FDA UDI
- 510(k) Number
- K062385 FDA UDI
- FDA Product Code
- ETD FDA UDI
- GMDN Term
- Tympanostomy tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tympanostomy tube
Armstrong X Vent Tube by Grace Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tympanostomy tube.
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Cleared under the same submission
K062385 also covers:
- ARMSTRONG R VENT TUBE — Grace Medical, Inc.
- ARMSTRONG R VENT TUBE — Grace Medical, Inc.
- ARMSTRONG R VENT TUBE — Grace Medical, Inc.
- ARMSTRONG R VENT TUBE — Grace Medical, Inc.
- ARMSTRONG X VENT TUBE — Grace Medical, Inc.
- BAXTER BEVELED BOBBIN — Grace Medical, Inc.
- BEVELED BOBBIN VENT TUBE — Grace Medical, Inc.
- BEVELED BOBBIN VENT TUBE — Grace Medical, Inc.
- BOBBIN VENT TUBE — Grace Medical, Inc.
- BOBBIN VENT TUBE — Grace Medical, Inc.
- DONALDSON VENT TUBE — Grace Medical, Inc.
- DONALDSON VENT TUBE — Grace Medical, Inc.
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
- Grace Medical, Inc.
Sources (1)
- FDA UDI 0fc56ed7-ca68-4559-8643-1b6b7be7072f 35 fields · synced Jun 1, 2026