FDA.reportPublic FDA data

General instrumentation

Primary DI
03662663037600
Brand
General instrumentation
Company
LDR Spine Usa, Inc.
Model
IG015R
Catalog number
IG015R
Published
2018-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662663037600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662663037600036626630376003662663037600

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length100Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-699-3360custserv@ldrspine.com

Regulatory Flags#

DUNS number
615789729
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662663000369Mobi-CMB942RMB942R2018-12-12
03662663002899Avenue TAT9033RAT9033R2017-04-12
03662663002912Avenue TAT9035RAT9035R2017-04-12
03662663033039VFTVF9004RVF9004R2017-05-19
03662663033169VFTVF9105RVF9105R2017-05-19
03662663036863EasyspineES9038RES9038R2018-12-11
03662663037402InterBRIDGEIB9003RIB9003R2018-12-12
03662663041447ROI-TIR9098RIR9098R2018-12-12
03662663041676ROI-AIR9202RIR9202R2017-03-23
03662663043076ROI-AIR9431RIR9431R2018-12-12
03662663043083ROI-AIR9432RIR9432R2018-12-12
03662663043175ROI-CMC9002RMC9002R2017-03-23
03662663043182ROI-CMC9003RMC9003R2017-03-23
03662663043632MC+MC908RMC908R2018-12-11
03662663043656ROI-CMC9092RMC9092R2017-03-23
03662663043663ROI-CMC9093RMC9093R2017-03-23
03662663043670ROI-CMC9094RMC9094R2017-03-23
03662663044165MC+MC937RMC937R2018-12-11
03662663044172MC+MC938RMC938R2018-12-11
03662663044332MC+MC960RMC960R2018-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649988948725SPIRECUTSPIRECUT SALRP2026-05-04
G586961003A0Novo SurgicalNOVO SURGICAL, INC.LRP2024-02-22
G429MSS820160Stainless steel bowl small 6CMMEED SKILL SURGICALLRP2023-03-03
G141588222990Carnegie Surgical LLCCarnegie Surgical LLCLRP2023-02-13
07899798205796QuinelatoSchobell Industrial LtdaLRP2022-12-20
10080196055159MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196818778MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196848041MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196996681MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10190001934897MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190021MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
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10193489190489MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
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10193489191189MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191240MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190199MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
10193489190205MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
10193489190212MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
10193489190250MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16