FDA.reportPublic FDA data

CRP™ Cuff Repair Plate System

Primary DI
00815482020046
Brand
CRP™ Cuff Repair Plate System
Company
Shoulder Options, Inc.
Model
45-IM-AB040
Catalog number
45-IM-AB040
Device description
Anchor Bolt, 40mm
Published
2015-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815482020046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815482020046008154820200468154820200460815482020046

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
704-512-0000burgan@shoulderoptions.com

Regulatory Flags#

DUNS number
053545528
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815482020022CRP™ Cuff Repair Plate System45-IM-AB05045-IM-AB0502015-11-02
00815482020039CRP™ Cuff Repair Plate System45-IM-AB04545-IM-AB0452015-11-02
00815482020053CRP™ Cuff Repair Plate System45-IM-AB03545-IM-AB0352015-11-02
00815482020060CRP™ Cuff Repair Plate System45-IM-AB03045-IM-AB0302015-11-02
00815482020077CRP™ Cuff Repair Plate System45-IM-AB02545-IM-AB0252015-11-02
00815482020084CRP™ Cuff Repair Plate System45-IM-AB02045-IM-AB0202015-11-02
00815482020091CRP™ Cuff Repair Plate System45-IM-AB01545-IM-AB0152015-11-02
00815482020107CRP™ Cuff Repair Plate System45-IM-AB01045-IM-AB0102015-11-02
00815482020138CRP™ Cuff Repair Plate System16-IN-KW15016-IN-KW1502015-11-02
00815482020220AFT™ Proximal Humerus Fracture Plate SystemSO02-3000SO02-30002015-11-02
00815482020237AFT™ Proximal Humerus Fracture Plate SystemSO02-3001SO02-30012015-11-02
00815482020244AFT™ Proximal Humerus Fracture Plate SystemSO02-3002SO02-30022015-11-02
00815482020251AFT™ Proximal Humerus Fracture Plate SystemSO02-3003SO02-30032015-11-02
00815482020268AFT™ Proximal Humerus Fracture Plate SystemSO02-3005-30SO02-3005-302015-11-02
00815482020275AFT™ Proximal Humerus Fracture Plate SystemSO02-3005-32.5SO02-3005-32.52015-11-02
00815482020282AFT™ Proximal Humerus Fracture Plate SystemSO02-3005-35SO02-3005-352015-11-02
00815482020299AFT™ Proximal Humerus Fracture Plate SystemSO02-3005-37.5SO02-3005-37.52015-11-02
00815482020305AFT™ Proximal Humerus Fracture Plate SystemSO02-3005-40SO02-3005-402015-11-02
00815482020312AFT™ Proximal Humerus Fracture Plate SystemSO02-3005-42.5SO02-3005-42.52015-11-02
00815482020329AFT™ Proximal Humerus Fracture Plate SystemSO02-3005-45SO02-3005-452015-11-02

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