Identity
- Trade Name
- Tuttnauer® FDA UDI
- Generic Name
- Biological sterilization indicator reader FDA UDI
- Device Name
- Auto-Reader Incubator for biological indicators FDA UDI
- Model / Reference
- WTL198-0079 FDA UDI
- Description
- Auto-Reader Incubator for biological indicators FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07798164677468 FDA UDI
- 510(k) Number
- K163646 FDA UDI
- FDA Product Code
- FRC FDA UDI
- GMDN Term
- Biological sterilization indicator reader FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2800 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
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Biological sterilization indicator reader
Tuttnauer® by Terragene S.a. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K163646 also covers:
- BIOTRACE™ — TERRAGENE S.A.
- BIOTRACE™ — TERRAGENE S.A.
- Bionova® — TERRAGENE S.A.
- Bionova® — TERRAGENE S.A.
- Bionova® — TERRAGENE S.A.
- Bionova® — TERRAGENE S.A.
- Bionova® — TERRAGENE S.A.
- Bionova® — TERRAGENE S.A.
- Bionova® — TERRAGENE S.A.
- Bionova® — TERRAGENE S.A.
- Bionova® — TERRAGENE S.A.
- Bionova® — TERRAGENE S.A.
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
- Terragene S.a.
Sources (1)
- FDA UDI 30490881-0e96-4378-8c19-009f6b32a06d 36 fields · synced Jun 1, 2026