FDA.reportPublic FDA data

Advanced Research Medical Trident SI Screw System

Primary DI
00840239800350
Brand
Advanced Research Medical Trident SI Screw System
Company
ADVANCED RESEARCH MEDICAL LLC
Model
03-2001
Catalog number
03-2001
Device description
Trident Case Assembly
Published
2021-04-12
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
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203373000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203373000Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC2021-01-22OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239800350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239800350008402398003508402398003500840239800350

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical instruments and related items for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6124401865info@advresmed.com

Regulatory Flags#

DUNS number
117201206
Device count
1
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
00850014575038Lumbar Interbody Fusion System (OLLIF)01-200101-20012019-12-16
00850014575076Lumbar Interbody Fusion System (OLLIF)01-271001-27102019-12-16
00850014575083Lumbar Interbody Fusion System (OLLIF)01-271101-27112019-12-16
00850014575090Lumbar Interbody Fusion System (OLLIF)01-271201-27122019-12-16
00850014575106Lumbar Interbody Fusion System (OLLIF)01-271301-27132019-12-16
00850014575113Lumbar Interbody Fusion System (OLLIF)01-271401-27142019-12-16
00850014575120Lumbar Interbody Fusion System (OLLIF)01-271501-27152019-12-16
00850014575144Lumbar Interbody Fusion System (OLLIF)01-300801-30082019-12-16
00850014575151Lumbar Interbody Fusion System (OLLIF)01-300901-30092019-12-16
00850014575168Lumbar Interbody Fusion System (OLLIF)01-301001-30102019-12-16
00850014575175Lumbar Interbody Fusion System (OLLIF)01-301101-30112019-12-16
00850014575182Lumbar Interbody Fusion System (OLLIF)01-301201-30122019-12-16
00850014575199Lumbar Interbody Fusion System (OLLIF)01-301301-30132019-12-16
00850014575205Lumbar Interbody Fusion System (OLLIF)01-301401-30142019-12-16
00850014575212Lumbar Interbody Fusion System (OLLIF)01-301501-30152019-12-16
00850014575229Lumbar Interbody Fusion System (OLLIF)01-331501-33152019-12-16
00850014575236Lumbar Interbody Fusion System (OLLIF)01-331401-33142019-12-16
00850014575243Lumbar Interbody Fusion System (OLLIF)01-331301-33132019-12-16
00850014575250Lumbar Interbody Fusion System (OLLIF)01-331201-33122019-12-16
00850014575267Lumbar Interbody Fusion System (OLLIF)01-331101-33112019-12-16

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