FDA.report

Dyna Locking Trochanteric Nail

Primary DI
08800015948968
Brand
Dyna Locking Trochanteric Nail
Company
U&I CORPORATION
Model
NG3024
Published
2017-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HTJGAUGE, DEPTH

Product Code Classifications

CodeDeviceSpecialtyClass
HTJGauge, DepthOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800015948968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800015948968088000159489688800015948968

GMDN Terms

TermDefinition
Orthopaedic implant/instrument depth limiterAn orthopaedic device designed to limit the depth of insertion of a surgical instrument (e.g., a drill bit or a reamer), a trial implant, or an implant. It may be used as a stand-alone device or it may be attached to another device to control the insertion depth; this can be to prevent the insertion of an instrument or implant below the surgical field of interest thereby avoiding damage to tissue behind or below the target structures. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
688811082
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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