Identity
- Trade Name
- aspen surgical®, PullUp, SlimFit EUDAMEDPullUp Probe Cover Kit FDA UDI
- Generic Name
- Intraoperative ultrasound imaging transducer cover FDA UDI
- Device Name
- Surgical Probe Covers (sterile) EUDAMED
- Model / Reference
- 1-519-2233 EUDAMED2233 FDA UDI
Identifiers
- Catalog Number
- 2233 FDA UDI
- Primary DI / UDI-DI
- 00841912100378 EUDAMEDFDA UDI
- Basic UDI-DI
- 0840113217000ST5L EUDAMED
- 510(k) Number
- K970893 FDA UDI
- FDA Product Code
- KKX FDA UDI
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Intraoperative ultrasound imaging transducer cover FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Intraoperative ultrasound imaging transducer cover
PullUp Probe Cover Kit by Protek Medical Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K970893 also covers:
- Coveralls — H R Pharmaceuticals, Inc.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Disposable Probe Cover — PROTEK MEDICAL PRODUCTS, INC.
- General Purpose Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- General Purpose Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- General Purpose Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Non-Sterile Endocavity Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Protek Medical Products, Inc.
Sources (2)
- FDA UDI 5bd0f0b3-ad3b-4391-a3c4-8abfef662f68 34 fields · synced Oct 7, 2026
- EUDAMED 2f5572a5-edec-4db0-b1e5-8f62e0640ed4 61 fields · synced Oct 7, 2026