FDA.report

KHEIRON

Primary DI
03701313002848
Brand
KHEIRON
Company
S.M.A.I.O
Model
01DG1010
Catalog number
01DG1010
Device description
Sacral plate drilling guide
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
03701313002848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03701313002848037013130028483701313002848

GMDN Terms

TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. 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

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03701313009557KHEIRON30KR600032026-01-27
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03701313009571KHEIRON30KR600012026-01-26
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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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