FDA.reportPublic FDA data

N/A

Primary DI
00840239800749
Brand
N/A
Company
ADVANCED RESEARCH MEDICAL LLC
Model
A-01
Catalog number
A-01
Device description
XL-Dilator
Published
2025-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00840239800749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239800749008402398007498402398007490840239800749

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(612) 440-1865info@advresmed.com

Regulatory Flags#

DUNS number
117201206
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150075034Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-10
07640177820907Neo Medical Pedicle screw kitNeo Medical SALXH2026-07-10
00840286860093Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
10705034647463N/AMedos International SàrlLXH2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49401B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49402B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49403B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49404B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49405B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49406B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49407B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49408B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49409B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49410B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49411B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49412B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49413B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49414B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49415B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49416B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49417B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49418B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49419B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49420B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500010Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500020Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500030Surgical DirectSurgical Direct, Inc.LXH2026-07-09