FDA.reportPublic FDA data

Guide Body

Primary DI
10818674022498
Brand
Guide Body
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
0234-109-200
Catalog number
148000st
Published
2021-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10818674022498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081867402249810818674022498

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail guidewire, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
534123013
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10810128462386GFS Mini Tray3910-800-024tg52420st2026-02-01
10810128461792GFS Hohmann Retractor3910-800-017la524HB002st2026-01-18
10810128461808GFS Glenoid Lever, Double Prong3910-800-018la524HB004st2026-01-18
10810128461815GFS Subscapularis Spreader3910-800-019la524HB001st2026-01-18
10810128461822GFS Glenoid Drill3910-800-020la524130st2026-01-18
10810128461839GFS Glenoid Guide3910-800-021la524v00st2026-01-18
10810128461846GFS Small Probe3910-800-022la524pb0st2026-01-18
10810128461655GFS Switching Stick3910-800-003la900130st2026-01-15
10810128461662GFS Inline Coracoid Drill Guide3910-800-004la524t00st2026-01-15
10810128461679GFS Coracoid Drill3910-800-005la524p01st2026-01-15
10810128461686GFS Coracoid Top Hat Drill3910-800-006la524p00st2026-01-15
10810128461693GFS Top Hat Tap3910-800-007la524400st2026-01-15
10810128461709GFS Sharp Curved Osteotome3910-800-008la524800st2026-01-15
10810128461716GFS Subscapularis Channeler3910-800-009la524900st2026-01-15
10810128461747GFS Glenoid Offset Pin3910-800-012la524u00st2026-01-15
10810128461754GFS Coracoid Screw, 3.5mm3910-800-013la524f00st2026-01-15

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