← Back to catalogue

Instrusafe

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref IN-2300-15

by Summit Medical, LLC

Identity

Trade Name
INSTRUSAFE EUDAMEDFDA UDI
Generic Name
Instrument tray, reusable FDA UDI
Device Name
InstruSafe Instrument Protection System - Trays, Accessories, and Transport Containers EUDAMED
Model / Reference
IN-2300-15 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
00385640034869 EUDAMEDFDA UDI
Basic UDI-DI
03856490146_INSTRUSAJP EUDAMED
Direct Marketing DI
00385640034869 EUDAMED
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
EMDN Code
V0402 CLINICAL USE TRAYS AND BOWLS EUDAMED
GMDN Term
Instrument tray, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
880.6850 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

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

Category: Instrument tray, reusable

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

Similar devices

Also classified as Instrument tray, reusable.

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 (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Summit Medical, LLC

Sources (2)

  • FDA UDI 956e3367-ca24-4c78-883a-421ff076ee68 33 fields · synced Jul 29, 2026
  • EUDAMED 59ec8fa9-96c1-4038-b10e-1e9bcc01957f 61 fields · synced Jul 29, 2026