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ITL EssentialsTM Sharps Passing Tray Large
EUDAMEDFDA UDIClass I (EU MDR)
Ref A500117
Identity
- Trade Name
- ITL EssentialsTM Sharps Passing Tray Large EUDAMEDITL Essentials™ Sharps Passing Tray Large FDA UDI
- Generic Name
- Surgical instrument interim-placement holder, single-use FDA UDI
- Device Name
- Sharps Passing Tray EUDAMEDITL Essentials™ Sharps Passing Tray Large is the sterile version of Sharps Passing Tray Large which is used for safe transfer of sharp surgical instruments during surgery. For single use only. FDA UDI
- Model / Reference
- A500117 EUDAMEDFDA UDI
- Description
- ITL Essentials™ Sharps Passing Tray Large is the sterile version of Sharps Passing Tray Large which is used for safe transfer of sharp surgical instruments during surgery. For single use only. FDA UDI
Identifiers
- Catalog Number
- A500117 FDA UDI
- Primary DI / UDI-DI
- 09555240401601 EUDAMEDFDA UDI
- Basic UDI-DI
- 955524040SPTSLW EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS EUDAMED
- GMDN Term
- Surgical instrument interim-placement holder, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
ITL EssentialsTM Sharps Passing Tray Large by Itl Asia Pacific Sdn. Bhd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 955524040SPTSLW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ITL Asia Pacific Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000001570
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 7333a332-9fa2-41d6-ba55-ac59cf829ebc 61 fields · synced Jun 18, 2026
- FDA UDI 0ff81914-68f4-4b2c-a4ca-8282ce50ed6e 36 fields · synced May 29, 2026