FDA.report

Trocar Tip Wire

Primary DI
B058SLNT331
Brand
Trocar Tip Wire
Company
Orthopedic Designs North America, Inc.
Model
SLNT33
Catalog number
SLN-T33
Device description
Trocar Tip Wire, 3mm x 900mm
Published
2018-03-26
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

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B058SLNT331PrimaryHIBCC0

GMDN Terms

TermDefinition
Bone nail guidewire, single-useA sterile, long, thin, metal rod designed to guide intramedullary canal devices for performing the implantation of an intramedullary nail to treat damaged bone. The rod is usually manually inserted into the canal to typically guide a surgical instrument (e.g., a reamer) and the implantable nail. This device is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). It may be used in femoral, tibial, humeral or supracondylar intramedullary canals. This is a single-use device.

Device Sizes

TypeValueUnit
Length900Millimeter
Outer Diameter3Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
888-635-8535support@odi-na.com

Regulatory Flags

DUNS number
945518848
Device count
1
DM exempt
false
Premarket exempt
true
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
true

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B058AHN5050NS1Atlas™ Humeral Nail SystemAHN5050NSAHN-5-050NS2025-05-23
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