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-2020-5208 FDA UDI

Identifiers

Primary DI / UDI-DI: 00385640071451 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

The INSTRUSAFE is a sterile instrument tray designed for safe and effective use in clinical settings, featuring a durable and adjustable design that accommodates various types of instruments.

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:

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 41e78c43-de37-4490-96d6-61a4a8042564 33 fields · synced Jul 27, 2026