FDA.reportPublic FDA data

SPIRECUT

Primary DI
07649988948725
Brand
SPIRECUT
Company
SPIRECUT SA
Model
SB-01-01.01
Published
2026-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07649988948725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07649988948725076499889487257649988948725

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Regulatory Flags#

DUNS number
480464362
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07649988948701SPIRECUTKIT-SI-CT-01.012026-05-04
07649988948718SPIRECUTKIT-SI-TF-01.012026-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462922260evonosevonos GmbH & Co. KGLRP2026-08-18
10198956523852CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-18
10198956289475CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-17
10198956512252CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-17
10198956554474CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-17
10198956557468CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-17
10198956558908CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-17
10198956559172CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-17
04054462921102evonosevonos GmbH & Co. KGLRP2026-08-14
04054462921119evonosevonos GmbH & Co. KGLRP2026-08-14
04054462922277evonosevonos GmbH & Co. KGLRP2026-08-14
04054462922284evonosevonos GmbH & Co. KGLRP2026-08-14
04054462922307evonosevonos GmbH & Co. KGLRP2026-08-14
04054462922314evonosevonos GmbH & Co. KGLRP2026-08-14
04054462922338evonosevonos GmbH & Co. KGLRP2026-08-14
04054462922369evonosevonos GmbH & Co. KGLRP2026-08-14
04054462922376evonosevonos GmbH & Co. KGLRP2026-08-14
04054462922383evonosevonos GmbH & Co. KGLRP2026-08-14
03661219288992LANDANGERLANDANGERLRP2026-08-09
03661219289050LANDANGERLANDANGERLRP2026-08-09
03661219289296LANDANGERLANDANGERLRP2026-08-09
10198956516014CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-31
10198956536043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-31
10198956538313CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-31
04046826380830Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826380939Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413187Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413194Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413200Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826438180Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30