FDA.report

CONTOUR MENISCUS ARROW

Primary DI
20845854017187
Brand
CONTOUR MENISCUS ARROW
Company
Conmed Corporation
Model
541113-3
Catalog number
541113-3
Device description
CONTOUR MENISCUS ARROW 1.1MM X 13MM,3/EA
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Product Code Classifications

CodeDeviceSpecialtyClass
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20845854017187PackageGS13In Commercial Distribution
10845854017180PrimaryGS10
00845854017183Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2084585401718720845854017187
1084585401718010845854017180
00845854017183008458540171838458540171830845854017183

GMDN Terms

TermDefinition
Meniscus screwA small, threaded, bioabsorbable rod intended to be used for the internal fixation of vertical lesions located in the vascularized area of the meniscus (a crescent-shaped disk of fibrocartilage that borders and partly covers the articulating surfaces of the tibia and femur at the knee). It is typically cannulated for guided percutaneous insertion. The device is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers).

Device Sizes

TypeValueUnit
Length13Millimeter
Outer Diameter1.1Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY
Storage Environment Temperature035 Degrees Celsius
Storage Environment Temperature095 Degrees Fahrenheit
Storage Environment Temperature0 Degrees Fahrenheit95 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags

DUNS number
071595540
Device count
3
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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