Identity
- Trade Name
- Kryo FDA UDI
- Generic Name
- Assisted reproduction freezer FDA UDI
- Device Name
- Kryo570-115 Kryo 570, 115V, 16 Litre Freezer System FDA UDI
- Model / Reference
- GDKRYO570-115 FDA UDI
- Description
- Kryo570-115 Kryo 570, 115V, 16 Litre Freezer System FDA UDI
Identifiers
- Primary DI / UDI-DI
- B199GDKRYO5701150 FDA UDI
- FDA Product Code
- KSP FDA UDI
- GMDN Term
- Assisted reproduction freezer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.9225 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Assisted reproduction freezerFreezer control unit, programmable
Kryo by Planer Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Freezer control unit, programmable.
- Kryo — Planer Plc · Class I
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- Kryo 360 Freezer — Planer Plc · Class I
- Kryo 750 Freezer - Front Loader — Planer Plc · Class I
- MRV Contoller — Planer Plc · Class I
- Kryo — Planer Plc · Class I
- MRV Controller Adaptor — PLANER LIMITED · Class I
- Kryo 360 Freezer — PLANER LIMITED · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Planer Limited
Sources (1)
- FDA UDI 9833fc0e-46b1-40be-b4fb-a374a7193519 33 fields · synced May 30, 2026