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-2020-6381 FDA UDI

Identifiers

Primary DI / UDI-DI: 00385640079853 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
K210836 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Instrument tray, reusable

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

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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:

K210836 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Summit Medical, LLC

Sources (1)

FDA UDI f31c795d-cab9-4682-973f-ecb9dd273312 33 fields · synced May 31, 2026