Identity
- Trade Name
- STRIPPER FDA UDI
- Generic Name
- Assisted reproduction microtool FDA UDI
- Device Name
- STRIPPER TIPS Multi-Pack FDA UDI
- Model / Reference
- MXL3-135 FDA UDI
- Description
- STRIPPER TIPS Multi-Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20888937906244 FDA UDI
- 510(k) Number
- K993699 FDA UDI
- FDA Product Code
- MQH FDA UDI
- GMDN Term
- Assisted reproduction microtool FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Assisted reproduction microtool
Stripper by Origio Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Assisted reproduction microtool.
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- TPC — CooperSurgical, Inc. · Class II
- ASTEC — ASTEC BIO USA INC · Class II
- ASTEC — ASTEC BIO USA INC · Class II
- EZ-Tip — Research Instruments , Ltd. · Class II
- RI Pipettes — Research Instruments , Ltd. · Class II
- ASTEC — ASTEC BIO USA INC · Class II
Cleared under the same submission
K993699 also covers:
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
- Origio Inc.
Sources (1)
- FDA UDI 6071dc74-b0d6-4e4a-9fe2-75c6196dc316 34 fields · synced May 30, 2026