CryoTube 4, 5 ml SI Internal thread star foot Round
FDA UDIEUDAMEDClass I (US FDA UDI)
by Nunc A/S
Identity
- Trade Name
- Nunc™ CryoTube, 4,5mL, sterile, internal thread, starfoot, round EUDAMEDCryoTube 4,5 ml SI Internal thread star foot Round FDA UDI
- Generic Name
- General specimen container IVD, no additive/medium FDA UDI
- Device Name
- Nunc™ CryoTube, 4,5mL, sterile, internal thread, starfoot, round EUDAMEDCryoTube 4,5 ml SI Internal thread star foot Round is used for storage and transportation of biological material for in vitro diagnostic. FDA UDI
- Model / Reference
- 379146 EUDAMEDFDA UDI
- Description
- CryoTube 4,5 ml SI Internal thread star foot Round is used for storage and transportation of biological material for in vitro diagnostic. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15713311000264 EUDAMEDFDA UDI
- Basic UDI-DI
- B-15713311000264 EUDAMED
- FDA Product Code
- FMH FDA UDI
- EMDN Code
- W050299 DEVICES FOR SAMPLES TRANSPORT - OTHER EUDAMED
- GMDN Term
- General specimen container IVD, no additive/medium FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: General specimen container IVD, no additive/medium
CryoTube 4, 5 ml SI Internal thread star foot Round by Nunc A/S — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nunc A/S
Sources (2)
- FDA UDI 3336d0eb-a515-4399-b866-45ade1cebb8d 33 fields · synced Jun 18, 2026
- EUDAMED c11ec45f-239b-4340-b0ae-24297c14566c 61 fields · synced Jun 18, 2026