FDA.report

Plate Holder Pin

Primary DI
09120069812879
Brand
Plate Holder Pin
Company
I.T.S. GmbH
Model
62511
Catalog number
62511
Device description
Plate Holder Pin, PROlock Radius Plate
Published
2018-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HWCScrew, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09120069812879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09120069812879091200698128799120069812879

GMDN Terms

TermDefinition
Orthopaedic ball spikeA hand-held manual surgical instrument used in the surgical wound to reposition a bone fragment during a surgical intervention. It is typically a robust instrument designed with a handle at the proximal end and a long, sturdy, shaft that terminates in a singularly pointed ball head at the distal end. It is typically made of high-grade stainless steel and/or synthetic material and is used by the surgeon to reposition and hold bone fragments. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
303456917
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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