FDA.reportPublic FDA data

CONDUIT

Primary DI
10705034557441
Brand
CONDUIT
Company
Medos International Sàrl
Model
PFT10700T
Catalog number
PFT10700T
Device description
CONDUIT TLIF Transforaminal Lumbar Interbody Shaver H 7mm
Published
2022-07-20
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

Contact Domains#

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
10705034557441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503455744110705034557441

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705032501GRYPHON Flex2089582089582024-05-17
10705034165448COUGAR1891555141891555142015-09-24
10886705022649RIGIDLOOP2320092320092015-09-01
10886705022656RIGIDLOOP2320112320112015-09-01
10886705022663RIGIDLOOP2320142320142015-09-01
10886705022670RIGIDLOOP2320162320162015-09-01
10886705022687RIGIDLOOP2320172320172015-09-01
10886705022694RIGIDLOOP2320182320182015-09-01
10886705022700RIGIDLOOP2320192320192015-09-01
10886705022717RIGIDLOOP2320212320212015-09-01
10886705022724RIGIDLOOP2320222320222015-09-01
10886705022731RIGIDLOOP2320232320232015-09-01
10886705022755RIGIDLOOP2320282320282015-09-01
10886705022830RIGIDLOOP2320372320372015-09-01
10886705024070RIGIDLOOP2180342180342015-09-01
10886705024094RIGIDLOOP2324472324472015-09-01
10886705024100RIGIDLOOP2324482324482015-09-01
10886705024117RIGIDLOOP2324492324492015-09-01
10886705026012TRUESPAN ORTHOCORD2281512281512016-07-07
10886705026029TRUESPAN ORTHOCORD2281522281522016-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506090998ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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