2.0 mm Inion CPS®

Primary DI
06438408000591
Brand
2.0 mm Inion CPS®
Company
Inion Oy
Model
1
Catalog number
PLT-1038
Device description
6 hole plate
Published
2023-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438408000591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438408000591064384080005916438408000591

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, bioabsorbableA small, implantable sheet of firm material that is attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is chemically degraded and typically absorbed by natural body processes (e.g., a degradable polymer). The device is typically used for smaller post-traumatic or pathological orthopaedic fractures (e.g., of the hand or wrist). It may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
367994657
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438408012099Inion CPS™ instrumentation1INS-92752026-01-21
06438408012105Inion CPS™ instrumentation1INS-92762026-01-21
06438408012112Inion CPS™ instrumentation1INS-92772026-01-21
06438408012129Inion CPS™ instrumentation1INS-92782026-01-21
06438408012136Inion CPS™ instrumentation1INS-92792026-01-21
M224INS900510Inion instrument1INS-90052016-08-31
M224INS90059Inion instrument0INS-90052016-08-31
M224INS901310Inion instrument1INS-90132016-08-31
M224INS90139Inion instrument0INS-90132016-08-31
M224INS902810Inion instrument1INS-90282016-08-31
M224INS90289Inion instrument0INS-90282016-08-31
M224INS90359Inion instrument0INS-90352016-08-31
M224INS90369Inion instrument0INS-90362016-08-31
M224INS90379Inion instrument0INS-90372016-08-31
M224INS907110Inion instrument1INS-90712016-08-31
M224INS90719Inion instrument0INS-90712016-08-31
M224INS909710Inion instrument1INS-90972016-08-31
M224INS90979Inion instrument0INS-90972016-08-31
06438408007958Inion BioRestore™1BRS-54322019-08-09
06438408007972Inion BioRestore™1BRS-54352019-08-09

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Primary DI, Brand, Company table
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