Identity
- Trade Name
- ITL Essentials™ Needle Mat (Sterile) FDA UDI
- Generic Name
- Sharp surgical instrument counting tray/pad, single-use FDA UDI
- Device Name
- ITL Essentials™ Needle Mat is a plastic lidded tray for collecting, counting and temporarily storing used sharps (suture needles and blades) in the surgical suite. FDA UDI
- Model / Reference
- A500101 FDA UDI
- Description
- ITL Essentials™ Needle Mat is a plastic lidded tray for collecting, counting and temporarily storing used sharps (suture needles and blades) in the surgical suite. FDA UDI
Identifiers
- Catalog Number
- A500101 FDA UDI
- Primary DI / UDI-DI
- 19555240401080 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- Sharp surgical instrument counting tray/pad, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ITL Essentials™ Needle Mat (Sterile) by Itl Asia Pacific Sdn. Bhd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Itl Asia Pacific Sdn. Bhd.
Sources (1)
- FDA UDI a9f51e82-7132-48ef-83ad-fac2cd717e8e 37 fields · synced May 30, 2026