FDA.reportPublic FDA data

Eagle

Primary DI
00811714035987
Brand
Eagle
Company
RESPONSIVE ORTHOPEDICS LLC
Model
000617-0000-P01
Catalog number
000617-0000-P01
Device description
Eagle Drill Guide - Packaged
Published
2024-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00811714035987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811714035987008117140359878117140359870811714035987

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and 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 or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
002745858
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811714036403Shadow Mini Instruments2859522859522026-02-03
00811714036427Shadow Knotless Instruments2859542859542026-02-03
00811714036397Shadow Mini All-Suture Anchor2859512859512025-05-14
00811714036380Shadow Instruments2859502859502025-12-31
00811714036373Shadow All-Suture Anchor2859492859492025-05-14
00811714036625Mini Superhawk Suture Anchor2859802859802025-12-09
00811714036632Mini Superhawk2859752859752025-12-09
00811714036663Mini Superhawk2859782859782025-12-09
00811714036670Mini Superhawk2859792859792025-12-09
00811714036731Osprey Suture Anchor2859852025-12-09
00811714036748Mini Superhawk Suture Anchor2859812859812025-12-09
00811714036144Superhawk2859252859252025-05-14
00811714036151Superhawk2859262859262025-05-14
00811714036168Superhawk2859272859272025-05-14
00811714036199Superhawk2859302859302025-05-14
00811714036205Superhawk2859312859312025-05-14
00811714036212Superhawk2859322859322025-05-14
00811714036229Superhawk2859332859332025-05-14
00811714036236Superhawk2859342859342025-05-14
00811714036243Superhawk2859362859362025-05-14

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Primary DI, Brand, Company table
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