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ChestShield Sterilization Tray System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 4700101Model TRAYSRef 4700202Ref 4700102Ref 4700201
Identity
- Trade Name
- ChestShield Sterilization Tray System EUDAMEDFDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Cases & Trays EUDAMEDSternalPlate Implant Module with Lid FDA UDIChestShield Instrument Tray Lid FDA UDIImplant Module Lid FDA UDISternalPlate Plate Inlay FDA UDI
- Model / Reference
- 4700201 EUDAMEDFDA UDI4700101 EUDAMEDFDA UDI4700102 EUDAMEDFDA UDI4700202 EUDAMEDFDA UDITRAYS EUDAMED
- Description
- SternalPlate Implant Module with Lid FDA UDIChestShield Instrument Tray Lid FDA UDIImplant Module Lid FDA UDISternalPlate Plate Inlay FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857387006466 EUDAMEDFDA UDI00857387006459 EUDAMEDFDA UDI00857387006473 EUDAMEDFDA UDI00857387006480 EUDAMEDFDA UDI
- Basic UDI-DI
- 0857387006TRAYAY EUDAMED
- Direct Marketing DI
- 00857387006459 EUDAMED00857387006480 EUDAMED00857387006473 EUDAMED00857387006466 EUDAMED
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Instrument tray, reusable
ChestShield Sterilization Tray System by Paragon Medical Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Instrument tray, reusable.
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- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- 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
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
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
- Paragon Medical Inc.
Sources (8)
- FDA UDI b949951f-66a1-4859-be65-661ad2fd757b 34 fields · synced Jul 21, 2026
- FDA UDI 33880045-f164-46be-99b6-221df33d82df 34 fields · synced May 29, 2026
- FDA UDI 637a7a66-b2f5-4dcc-bd20-dd60672fc194 34 fields · synced May 30, 2026
- FDA UDI c16d6ba8-7076-4b92-97b1-77fafc3ee9f6 34 fields · synced May 30, 2026
- EUDAMED 85214a04-1f4b-4b8d-8eec-85952f44b25a 61 fields · synced Jul 9, 2026
- EUDAMED 3e356912-0857-489a-b278-d2640b51a8a7 61 fields · synced Jul 9, 2026
- EUDAMED e02b27bf-0216-4aff-8d20-4afcbf2141a4 61 fields · synced Jul 11, 2026
- EUDAMED 7acc97b6-19c8-4ad8-ab9b-9414ac1a686e 61 fields · synced Jul 21, 2026