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-2020-3997 FDA UDI

Identifiers

Primary DI / UDI-DI: 00385640063883 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: 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

Instructive medical device review and comparison for the INSTRUSAFE sterilization wrap container, tray, cassette, or accessory. The device is designed for safe handling and storage of various medical instruments and supplies.

Similar devices

Also classified as Instrument tray, reusable.

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Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
Instrument Case — Katena Products, Inc. · Class I
Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
ASELTECH — Asel Tibbi Aletler A.S. · Class I

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

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 57efb987-2e30-46cb-b73c-3b2c92f6e8e3 33 fields · synced Jun 24, 2026