FDA.reportPublic FDA data

KHEIRON

Primary DI
03701313009410
Brand
KHEIRON
Company
S.M.A.I.O
Model
01HA2010
Device description
"1/4"" square female, Large Hudson male adaptor"
Published
2026-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701313009410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701313009410037013130094103701313009410

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool adaptorA connecting device designed as a mechanical coupling to join and lock together a distal tool to the surgical power tool to provide the power when these are incompatible and are of a different manufacture/industry standard. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and sizes. This device may be cannulated to allow the use of a guidewire. There are various types such as a Hudson adaptor, Trinkle adaptor, Zimmer adaptor. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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

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Primary DI, Brand, Company table
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