FDA.reportPublic FDA data

MITEK CRUCIATE+

Primary DI
10886705025831
Brand
MITEK CRUCIATE+
Company
Medos International Sàrl
Model
219004
Catalog number
219004
Device description
MITEK CRUCIATE+ Retrograde Reamer Bullet 4.8mm 15-85mm Plus or Minus 8 Percent
Published
2016-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
10886705025831PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670502583110886705025831

GMDN Terms#

Term, Definition table
TermDefinition
Ligament reconstruction instrument set, reusableA collection of surgical instruments intended to be used to prepare a joint for the reconstruction of damaged or torn ligaments, using a replacement device or tissue graft, during open or arthroscopic orthopaedic surgery. It typically consists of one or more guides, carriages, drill bits, reamers, burs, pushers, introducers, a staple impactor, and a surgical hammer. The set may be designed for specific joints, such as the shoulder or knee, and may assist in aligning the bone tunnels to allow isometric implantation of the ligament replacement device or graft. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705002085BIOKNOTLESS ORTHOCORD ETHIBOND2127222127222015-09-01
10886705002122BIOKNOTLESS ORTHOCORD ETHIBOND2127262127262015-09-01
10886705007530HEALIX PEEK ORTHOCORD2222052222052015-09-01
10886705007554HEALIX PEEK ORTHOCORD2222072222072015-09-01
10886705007578HEALIX PEEK ORTHOCORD2222092222092015-09-01
10886705007585HEALIX PEEK ORTHOCORD2222102222102015-09-01
10886705007639HEALIX PEEK ORTHOCORD2222152222152015-09-01
10886705007677HEALIX PEEK ORTHOCORD2222192222192015-09-01
10886705007691HEALIX PEEK ORTHOCORD2222212222212015-09-01
10886705007769ORTHOCORD HEALIX BR2222292222292015-09-01
10886705007783ORTHOCORD HEALIX BR2222322222322015-09-01
10886705007790ORTHOCORD HEALIX BR2222332222332015-09-01
10886705007844ORTHOCORD HEALIX BR2222382222382015-09-01
10886705007851ORTHOCORD HEALIX BR2222392222392015-09-01
10886705013616INTRAFIX2546802546802015-09-01
10886705013623INTRAFIX2546812546812015-09-01
10886705013630INTRAFIX2546822546822015-09-01
10886705013647INTRAFIX2546832546832015-09-01
10886705013654INTRAFIX2546842546842015-09-01
10886705013661INTRAFIX2546852546852015-09-01

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