Identity
- Trade Name
- ADD FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Layer for ADD/small VBR instruments FDA UDI
- Model / Reference
- CS 2258-2 FDA UDI
- Description
- Layer for ADD/small VBR instruments FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04052536009510 FDA UDI
- 510(k) Number
- K192117 FDA UDI
- FDA Product Code
- MQR FDA UDIPLR FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3610 FDA UDI888.3060 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Device sterilization/disinfection container, reusable
Add by Ulrich GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Device sterilization/disinfection container, reusable.
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Cleared under the same submission
K192117 also covers:
- ADD — Ulrich GmbH & Co. KG
- ADDplus — Ulrich GmbH & Co. KG
- ADDplus — Ulrich GmbH & Co. KG
- ADDplus™, ADD™, VBR™, topaz™ — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ulrich GmbH & Co. KG
Sources (2)
- FDA UDI 5e6025b0-f18c-405a-a20a-c649c39ec4aa 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026