Identity
- Trade Name
- Kryo 360 Freezer FDA UDI
- Generic Name
- Assisted reproduction freezer FDA UDI
- Device Name
- Kryo 360 Controlled Rate Freezer. 3.3 litre Chamber Only FDA UDI
- Model / Reference
- GDKRYO360CH-3.3-115 FDA UDI
- Description
- Kryo 360 Controlled Rate Freezer. 3.3 litre Chamber Only FDA UDI
Identifiers
- Primary DI / UDI-DI
- B199GDKRYO360CH331150 FDA UDI
- FDA Product Code
- MQG FDA UDI
- GMDN Term
- Assisted reproduction freezer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6120 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Assisted reproduction freezer
Kryo 360 Freezer by Planer Plc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assisted reproduction freezer.
- Kryo 360 Freezer — PLANER LIMITED · Class I
- Thermo Scientific Forma — Thermo Fisher Scientific (Asheville) LLC · Class II
- Thermo Scientific Forma — Thermo Fisher Scientific (Asheville) LLC · Class II
- Kryo 360 Freezer — PLANER LIMITED · Class II
- Kryo — PLANER LIMITED · Class I
- Kryo 360 Freezer — PLANER LIMITED · Class I
- Thermo Scientific Forma — Thermo Fisher Scientific (Asheville) LLC · Class II
- Thermo Scientific Forma — Thermo Fisher Scientific (Asheville) LLC · Class II
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
- Planer Plc
Sources (1)
- FDA UDI 1949b4dc-6fe0-442a-9a28-a69aff1e3442 34 fields · synced Jun 8, 2026