Identity
- Trade Name
- SMTP FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Sterilization box FDA UDI
- Model / Reference
- XDF06801 FDA UDI
- Description
- Sterilization box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972603519217 FDA UDI
- 510(k) Number
- K201274 FDA UDI
- FDA Product Code
- JDX FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.4580 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
MR Unsafe FDA UDI
Category: Instrument tray, reusable
Smtp by SMTP Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Instrument tray, reusable.
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- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
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Cleared under the same submission
K201274 also covers:
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
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
- SMTP Medical Co., Ltd.
Sources (1)
- FDA UDI cc549fd8-3f76-49fb-b0c8-7bc0b3002c02 34 fields · synced May 30, 2026