FDA.reportPublic FDA data

KHEIRON

Primary DI
03701313001926
Brand
KHEIRON
Company
S.M.A.I.O
Model
01RK0011
Catalog number
01RK0011
Device description
#1 pedicle screws rack
Published
2020-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701313001926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701313001926037013130019263701313001926

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+33469842302contact@smaio.com

Regulatory Flags#

DUNS number
260585710
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701313005177KHEIRON29TC6030229TC603022024-06-24
03701313005184KHEIRON29TC6030129TC603012024-06-24
03701313005191KHEIRON29TC6020229TC602022024-06-24
03701313005207KHEIRON29TC6020129TC602012024-06-24
03701313005214KHEIRON29TC6010229TC601022024-06-24
03701313005221KHEIRON29TC6010129TC601012024-06-24
03701313005238KHEIRON29TC5530229TC553022024-06-24
03701313005245KHEIRON29TC5530129TC553012024-06-24
03701313005252KHEIRON29TC5520229TC552022024-06-24
03701313005269KHEIRON29TC5520129TC552012024-06-24
03701313005276KHEIRON29TC5510229TC551022024-06-24
03701313005283KHEIRON29TC5510129TC551012024-06-24
03701313000028KHEIRON24TS0293124TS029312020-12-14
03701313000035KHEIRON24TS0313524TS031352020-12-14
03701313000042KHEIRON24TS0354324TS035432020-12-14
03701313000073KHEIRON24CR5541524CR554152020-12-14
03701313000080KHEIRON24CR5561524CR556152020-12-14
03701313000097KHEIRON24CR5591524CR559152020-12-14
03701313000103KHEIRON24CR5540524CR554052020-12-14
03701313000110KHEIRON24CR5560524CR556052020-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630055307736ACE Acetabular Reamer Tray - Instrument TrayIncipio Devices SAFSM2026-04-30
07613327652765TPXSTRYKER CORPORATIONFSM2026-03-25
07613327631852RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631869RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631876RPSSTRYKER CORPORATIONFSM2025-10-01
07613327681741N/ASTRYKER CORPORATIONFSM2025-09-03
ESAM23080001STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080161STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6550401STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
07630894802683APTUSMedartis AGFSM2023-02-24
07630894802973APTUSMedartis AGFSM2023-02-24
07630894802980APTUSMedartis AGFSM2023-02-24
07630894802997APTUSMedartis AGFSM2023-02-24
07630894803208APTUSMedartis AGFSM2023-02-24
07630894803215APTUSMedartis AGFSM2023-02-24
07630894803222APTUSMedartis AGFSM2023-02-24
07630894803246APTUSMedartis AGFSM2023-02-24
07630894803260APTUSMedartis AGFSM2023-02-24
07630894803307APTUSMedartis AGFSM2023-02-24
07630894803314APTUSMedartis AGFSM2023-02-24
07630894803321APTUSMedartis AGFSM2023-02-24
07630894803338APTUSMedartis AGFSM2023-02-24
07630894803345APTUSMedartis AGFSM2023-02-24
07630894803369APTUSMedartis AGFSM2023-02-24
07630894803383APTUSMedartis AGFSM2023-02-24
07630894803390APTUSMedartis AGFSM2023-02-24
07630894803413APTUSMedartis AGFSM2023-02-24