FDA.report

KHEIRON

Primary DI
03701313002145
Brand
KHEIRON
Company
S.M.A.I.O
Model
01BC3010
Catalog number
01BC3010
Device description
Right Ø5.5 rod coronal bender
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

Product Codes

CodeName
HXWBender

Product Code Classifications

CodeDeviceSpecialtyClass
HXWBenderOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03701313002145PrimaryGS10

GMDN Terms

TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. 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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