← Back to catalogue

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
Sheet, Level 4 extra large FDA UDI
Model / Reference
SHEET0540720-4-SV-0MDGN-000 FDA UDI
Description
Sheet, Level 4 extra large FDA UDI

Identifiers

Catalog Number
3873 FDA UDI
Primary DI / UDI-DI
00850057346145 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Elevate Textiles

Sources (1)

  • FDA UDI 33e78d45-1cdb-415b-8d7f-366d552938c7 36 fields · synced May 30, 2026