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Instrusafe

FDA UDI

Class II (US FDA UDI)

by Summit Medical, LLC

Identity

Trade Name
INSTRUSAFE FDA UDI
Generic Name
Instrument tray, reusable FDA UDI
Model / Reference
IN-2020-4269 FDA UDI

Identifiers

Primary DI / UDI-DI
00385640055215 FDA UDI
510(k) Number
K051157 FDA UDI
K133015 FDA UDI
K140289 FDA UDI
K141513 FDA UDI
K142630 FDA UDI
K142768 FDA UDI
K150540 FDA UDI
K151166 FDA UDI
FDA Product Code
KCT FDA UDI
GMDN Term
Instrument tray, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6850 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Instrusafe by Summit Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K051157 also covers:

K133015 also covers:

K140289 also covers:

K141513 also covers:

K142630 also covers:

K142768 also covers:

K150540 also covers:

K151166 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Summit Medical, LLC

Sources (1)

  • FDA UDI 1c385473-a273-4649-86e7-b98da73685cd 34 fields · synced May 31, 2026