FDA.report

KHEIRON

Primary DI
03701313002091
Brand
KHEIRON
Company
S.M.A.I.O
Model
01DR3020
Catalog number
01DR3020
Device description
Distractor
Published
2020-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03701313002091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03701313002091037013130020913701313002091

GMDN Terms

TermDefinition
Bone distraction forcepsA hand-held, manual, open-surgery instrument with sturdy handles and blade-like jaws designed to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. It has a scissors-like lever action with straight or curved handles and is typically made of high-grade stainless steel. It is available in various sizes with the distraction blades at the working end which are activated through a single or double-jointed pivot that transfers the necessary force to create distraction; the blades are typically short and slender to fit between bone segments or pre-implanted pedicle screws. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+33469842302contact@smaio.com

Regulatory Flags

DUNS number
260585710
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
03701313009410KHEIRON01HA20102026-02-17
03701313009540KHEIRON30KR600042026-01-27
03701313009557KHEIRON30KR600032026-01-27
03701313009595KHEIRON30KR550042026-01-27
03701313009601KHEIRON30KR550032026-01-27
03701313009571KHEIRON30KR600012026-01-26
03701313009625KHEIRON30KR550012026-01-26
03701313008024KHEIRON01DN20112025-04-08
03701313009366KHEIRON01DS202401DS20242025-03-14
03701313001001KHEIRON24PW6506524PW650652024-06-24
03701313001094KHEIRON24PW7506524PW750652024-06-24
03701313001100KHEIRON24PW7507024PW750702024-06-24
03701313001117KHEIRON24PW7508024PW750802024-06-24
03701313001124KHEIRON24PW7509024PW750902024-06-24
03701313001131KHEIRON24PW7510024PW751002024-06-24
03701313001148KHEIRON24PW7511024PW751102024-06-24
03701313001247KHEIRON24PW8506524PW850652024-06-24
03701313001254KHEIRON24PW8507024PW850702024-06-24
03701313001261KHEIRON24PW8508024PW850802024-06-24
03701313001278KHEIRON24PW8509024PW850902024-06-24

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