Identity
- Trade Name
- Faeces tube 101x16.5mm FDA UDI
- Generic Name
- Faecal specimen container IVD, no additive FDA UDI
- Model / Reference
- 80.623 FDA UDI
Identifiers
- Catalog Number
- 80.623 FDA UDI
- Primary DI / UDI-DI
- 04038917082983 FDA UDI
- FDA Product Code
- KDT FDA UDI
- GMDN Term
- Faecal specimen container IVD, no additive FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Faecal specimen container IVD, no additive
Faeces tube 101x16.5mm by Sarstedt Aktiengesellschaft & Co.KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Faecal specimen container IVD, no additive.
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
- Gongdong — Zhejiang Gongdong Medical Technology Co., Ltd., · Class I
- LIAISON Q.S.E.T. Device — Diasorin Inc.
- Para-Pak Direct Detect — MERIDIAN BIOSCIENCE, INC. · Class I
- Para-Pak Direct Detect — MERIDIAN BIOSCIENCE, INC. · Class I
- Aero-Med — AERO-MED LLC · Class I
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
- Globe Scientific — GLOBE SCIENTIFIC, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sarstedt Aktiengesellschaft & Co.KG
Sources (1)
- FDA UDI 9b7ebf67-9481-4ef0-8d9e-125d697ff20a 34 fields · synced Jun 8, 2026