Identity
- Trade Name
- GM501 Gradient 90% FDA UDI
- Generic Name
- Cell centrifugation/density gradient separation reagent IVD FDA UDI
- Device Name
- GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICSI procedures. FDA UDI
- Model / Reference
- 4GM501GR-90-250 FDA UDI
- Description
- GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICSI procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858604006207 FDA UDI
- 510(k) Number
- K053494 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- Cell centrifugation/density gradient separation reagent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6180 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
Yes
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: Cell centrifugation/density gradient separation reagent IVD
GM501 Gradient 90% by HAMILTON THORNE, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K053494 also covers:
- Sil-Select Stock — Fertipro NV
- Sil-Select Stock — Fertipro NV
- Sil-Select Stock — Fertipro NV
- SpermFreeze — Fertipro NV
- SpermFreeze — Fertipro NV
- SpermFreeze SSP — Fertipro NV
- SpermFreeze SSP — Fertipro NV
- SpermFreeze SSP — Fertipro NV
- SpermFreeze SSP — Fertipro NV
- GM501 Gradient 100% — HAMILTON THORNE, Inc.
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- HAMILTON THORNE, Inc.
Sources (1)
- FDA UDI 215460df-e6ce-46dd-a15d-3c34c59d6632 35 fields · synced May 30, 2026