FDA.reportPublic FDA data

Pathfinder™ ACL System

Primary DI
50850039930060
Brand
Pathfinder™ ACL System
Company
Danamed, Inc.
Model
024GP
Device description
Flexible Guide Pin with Sheath Adaptor, 1 Guide Pin, 1 Sheath
Published
2023-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50850039930060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5085003993006050850039930060

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, single-useA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080919105
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850039930065Pathfinder™ ACL System024GP2023-02-28
10850039930062Pathfinder™ ACL System024GP2023-02-28
20850039930069Pathfinder™ ACL System024GP2023-02-28
30850039930066Pathfinder™ ACL System024GP2023-02-28
40850039930063Pathfinder™ ACL System024GP2023-02-28
00850039930003Pathfinder™ ACL System0155R0155R2023-02-16
00850039930010Pathfinder™ ACL System0155L0155L2023-02-16
00850039930027Pathfinder™ ACL System0170R0170R2023-02-16
00850039930034Pathfinder™ ACL System0170L0170L2023-02-16
00850039930041Pathfinder™ ACL System0180R0180R2023-02-16
00850039930058Pathfinder™ ACL System0180R0180R2023-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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