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SRI Healthcare

FDA UDI

Class II (US FDA UDI)

by Elevate Textiles

Identity

Trade Name
SRI Healthcare FDA UDI
Generic Name
General surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Mayo Stand Cover FDA UDI
Model / Reference
MSC054064000-4-SV-0MDGN-000 FDA UDI
Description
Mayo Stand Cover FDA UDI

Identifiers

Catalog Number
3010 FDA UDI
Primary DI / UDI-DI
00850057346220 FDA UDI
510(k) Number
K080796 FDA UDI
FDA Product Code
KKX FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 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

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: General surgical procedure kit, non-medicated, reusable

SRI Healthcare by Elevate Textiles — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General surgical procedure kit, non-medicated, reusable.

Cleared under the same submission

K080796 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elevate Textiles

Sources (1)

  • FDA UDI c51ca529-aa1b-4f61-8ad9-c6d49afd7070 36 fields · synced Jun 8, 2026