FDA.report

NA

Primary DI
20845854017156
Brand
NA
Company
Conmed Corporation
Model
BXS6225
Catalog number
BXS6225
Device description
1.5MM BONE FIXATION KIT, DIAMETER 1.5 X 25MM, QTY 2
Published
2015-10-24
Public version status
Update
Distribution status
Not 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
HWCScrew, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20845854017156PackageGS12Not in Commercial Distribution
10845854017156PrimaryGS10
00845854017156Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2084585401715620845854017156
1084585401715610845854017156
00845854017156008458540171568458540171560845854017156

GMDN Terms

TermDefinition
Orthopaedic bone pin, bioabsorbableA device in the form of a small diameter rod intended to be used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis, in the presence of additional immobilization. The rod may be smooth or partially threaded. The device is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., degradable polymers such as polydioxanone or polyglycolide). This is a single-use device.

Device Sizes

TypeValueUnit
Length25Millimeter
Outer Diameter1.5Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
071595540
Device count
2
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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