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Sandel

FDA UDI

Class I (US FDA UDI)

by Ansell Sandel Medical Solutions LLC

Identity

Trade Name
SANDEL FDA UDI
Generic Name
Instrument tray, single-use FDA UDI
Device Name
Z-TRAY, W/ADHESIVE, BULK (NS) FDA UDI
Model / Reference
1145-NS FDA UDI
Description
Z-TRAY, W/ADHESIVE, BULK (NS) FDA UDI

Identifiers

Catalog Number
1145-NS FDA UDI
Primary DI / UDI-DI
25414566810185 FDA UDI
FDA Product Code
MDM FDA UDI
GMDN Term
Instrument tray, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Instrument tray, single-use

Sandel by Ansell Sandel Medical Solutions LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Instrument tray, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ansell Sandel Medical Solutions LLC

Sources (1)

  • FDA UDI e722b183-295d-40c5-b9d1-ce51195f93fd 35 fields · synced May 30, 2026