FDA.reportPublic FDA data

A/M Guide - RIGHT ACL, 6mm

Primary DI
10810190016005
Brand
A/M Guide - RIGHT ACL, 6mm
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
C
Catalog number
tg108018fst
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10810190016005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081019001600510810190016005

GMDN Terms#

Term, Definition table
TermDefinition
Ligament reconstruction instrument set, reusableA collection of surgical instruments intended to be used to prepare a joint for the reconstruction of damaged or torn ligaments, using a replacement device or tissue graft, during open or arthroscopic orthopaedic surgery. It typically consists of one or more guides, carriages, drill bits, reamers, burs, pushers, introducers, a staple impactor, and a surgical hammer. The set may be designed for specific joints, such as the shoulder or knee, and may assist in aligning the bone tunnels to allow isometric implantation of the ligament replacement device or graft. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
534123013
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

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10810128462850StayPort™ Cannula 9 mm x 13 cmAR-6593-09-13159130ar2026-07-16
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10810128462898VersiTILT Button, 2.4x8.5mm3910-700-013505103st2026-07-16
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10810128462911VersiTILT 2.4x12mm Button and Inserter, Long3910-700-021505201st2026-07-16
10810128462928VersiTILT Button, 2.4x12mm3910-700-023505203st2026-07-16
10810128462935VersiTILT 3.1x10.9mm Implant System, XL3910-700-030505300st2026-07-16
10810128462942VersiTILT 3.1x10.9mm Button and Inserter, XL3910-700-031505301st2026-07-16
10810128462959VersiTILT Drill Pin, 3.6mm3910-700-032505302st2026-07-16
10810128462966VersiTILT Button, 3.1x10.9mm3910-700-033505303st2026-07-16
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