Identity
- Trade Name
- Sil-Select Plus Upper Layer FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Sil-Select Plus Upper Layer - SIP020UP (20 ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer For the latest version of the intructions for use and MSDS, visit our product page on the FertiPro's website (www.fertipro.com) FDA UDI
- Model / Reference
- SIP020UP FDA UDI
- Description
- Sil-Select Plus Upper Layer - SIP020UP (20 ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer For the latest version of the intructions for use and MSDS, visit our product page on the FertiPro's website (www.fertipro.com) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 54119670010330 FDA UDI
- 510(k) Number
- K053494 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- IVF medium FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sil-Select Plus Upper Layer by Fertipro NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K053494 also covers:
- Sil-Select Stock — Fertipro NV
- Sil-Select Stock — Fertipro NV
- Sil-Select Stock — Fertipro NV
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- SpermFreeze — Fertipro NV
- SpermFreeze SSP — Fertipro NV
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- SpermFreeze SSP — Fertipro NV
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- GM501 Gradient 100% — HAMILTON THORNE, Inc.
- GM501 Gradient 100% — HAMILTON THORNE, 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
- Fertipro NV
Sources (1)
- FDA UDI a266321c-b3ac-443d-84be-6a657dfb3bd1 37 fields · synced May 30, 2026