Identity
- Trade Name
- Sterile Specimen Container FDA UDI
- Generic Name
- General specimen container IVD, no additive/medium FDA UDI
- Device Name
- 120ml/53mmSPC NO LBL,OR CAP,ST FDA UDI
- Model / Reference
- 070000 FDA UDI
- Description
- 120ml/53mmSPC NO LBL,OR CAP,ST FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17503025060139 FDA UDI
- FDA Product Code
- FMH FDA UDI
- GMDN Term
- General specimen container IVD, no additive/medium FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Sterile Specimen Container by Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
Sources (1)
- FDA UDI 980752d9-08e3-4805-aff7-4f3da439e8b8 34 fields · synced May 31, 2026