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InstruSafe IN-7837-TF

by Summit Medical, LLC

Ref IN-7837-TF

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210836

+8 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number03856490146_INSTRUSAJP Basic UDI-DI 00385640081580UDI-DIDate27 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00385640081580 UDI-DI Date24 Jun 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK210836 Date30 Nov 2021IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Instrusafe
Generic name
Instrument tray, reusable
Device name
InstruSafe Instrument Protection System - Trays, Accessories, and Transport Containers
Model / reference
IN-7837-TF
Primary DI / UDI-DI
00385640081580
Basic UDI-DI
03856490146_INSTRUSAJP
Direct marketing DI
00385640081580
510(k) Number
FDA product code
KCT
EMDN code
V0402 Clinical use trays and bowls
GMDN term
Instrument tray, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6850
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An instrument tray, reusable, is a container intended to provide a suitable platform for placing or containing many medical, surgical, or dental instruments and related items for use during a clinical procedure. It may also be used during, but not dedicated to, reprocessing or sterilization procedures. It is a receptacle with moulded positions for placing instruments and may include a lid and/or removable identification tags.

This reusable device is supplied non-sterile and requires prior sterilization before use. It is not single-use, does not contain MRI safety information in its labeling, and is available over-the-counter. The device has a lot or batch number and a manufacturing date, and is identified by the GS1 primary identifier 00385640081580.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the INSTRUSAFE instrument tray used for?

    The INSTRUSAFE instrument tray is a reusable container designed to hold and organize medical, surgical, or dental instruments during clinical procedures; it provides a stable platform with moulded positions for instruments and may include a lid or identification tags for efficient setup and handling.

  • Is the INSTRUSAFE tray sterile when supplied, and what preparation is needed before use?

    The INSTRUSAFE tray is supplied non-sterile and must undergo sterilization by the user prior to each clinical use; it is not single-use and is designed for repeated use after proper cleaning and sterilization cycles.

  • How is the INSTRUSAFE tray identified and tracked?

    Each INSTRUSAFE tray includes a lot or batch number, manufacturing date, and GS1 primary identifier 00385640081580 for traceability; it does not have a serial number or expiration date, and is distributed as a single unit per package.

Properties

  • Over-the-counter
  • Lot / batch number
  • Manufacturing date

Other properties (22)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No