Identity
- Trade Name
- Sterion® Cautery Tip Cleaner FDA UDI
- Generic Name
- Electrosurgical tip cleaning pad FDA UDI
- Device Name
- Provides a method of removing eschar build-up from the tip of an electrosurgical instrument during a procedure. FDA UDI
- Model / Reference
- 100BN FDA UDI
- Description
- Provides a method of removing eschar build-up from the tip of an electrosurgical instrument during a procedure. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840113228119 FDA UDI
- 510(k) Number
- K030339 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical tip cleaning pad FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrosurgical tip cleaning pad
Sterion® Cautery Tip Cleaner by Aspen Surgical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrosurgical tip cleaning pad.
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- Medical Action Industries — MEDICAL ACTION INDUSTRIES INC. · Class II
- Devon — Cardinalhealth · Class I
- Devon — Cardinalhealth · Class I
- Devon — Cardinal Health 200, LLC · Class I
- Symmetry Olsen — Olsen Medical · Class II
- Cautery Tip Cleaner — XODUS MEDICAL, INC. · Class II
Cleared under the same submission
K030339 also covers:
- Sterion® Cautery Tip Cleaner — Aspen Surgical Products, Inc.
- Sterion® Cautery Tip Cleaner — Aspen Surgical Products, Inc.
- Sterion® Cautery Tip Cleaner — Aspen Surgical Products, Inc.
- Sterion® Cautery Tip Cleaner — Aspen Surgical Products, Inc.
- Sterion® Cautery Tip Cleaner — Aspen Surgical Products, Inc.
- Sterion® Cautery Tip Cleaner — Aspen Surgical Products, Inc.
- DeRoyal — DEROYAL INDUSTRIES, INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- Medical Action Industries — MEDICAL ACTION INDUSTRIES INC.
- Medical Action Industries — MEDICAL ACTION INDUSTRIES INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Medichoice — OWENS & MINOR DISTRIBUTION, 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
- Aspen Surgical Products, Inc.
Sources (1)
- FDA UDI 69d92f8f-2d27-424a-bb34-61c65482261c 35 fields · synced Jun 9, 2026