FDA.reportPublic FDA data

Accessories, arthroscopic

Primary DI
00816342020626
Brand
Accessories, arthroscopic
Company
PARCUS MEDICAL LLC
Model
10090
Device description
7mm GRAFT SIZER
Published
2022-12-06
Public version status
Update
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
NBHAccessories, arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816342020626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816342020626008163420206268163420206260816342020626

GMDN Terms#

Term, Definition table
TermDefinition
Ligament graft sizer, noninvasiveA surgical instrument that contains a series of holes of varying dimensions/sizes intended to be used in orthopaedic surgery [e.g., in anterior cruciate ligament (ACL) reconstruction surgery] to measure the size/diameter of a harvested graft to be implanted. It is used ex vivo [e.g., on the preparation table of the operating room (OR)] on a harvested graft. The measurement is subsequently used to determine the diameter of the tunnel drilled into the operative site (e.g., distal femur) for acceptance of the new graft. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
859961950
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
00816342022033Graft Fixation System200422025-09-16
00816342022040Graft Fixation System200492025-09-16
00816342022057Graft Fixation System200532025-09-16
00816342022064Graft Fixation System200542025-09-16
00816342022071Graft Fixation System200552025-09-16
00816342022088Graft Fixation System200562025-09-16
00816342022095Graft Fixation System200592025-09-16
00816342022101Graft Fixation System200602025-09-16
00816342023887Graft Fixation System200462025-09-16
00816342023900Graft Fixation System200502025-09-16
00816342023955Graft Fixation System20042S2025-09-16
00816342024204Graft Fixation System20049S2025-09-16
00816342024211Graft Fixation System20035S2025-09-16
00816342024228Graft Fixation System20055S2025-09-16
00816342024235Graft Fixation System20054S2025-09-16
00816342024242Graft Fixation System20059S2025-09-16
00816342024259Graft Fixation System20053S2025-09-16
00816342024266Graft Fixation System20056S2025-09-16
00816342024273Graft Fixation System20032S2025-09-16
00816342024280Graft Fixation System20034S2025-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327053067NASTRYKER CORPORATIONNBH2021-09-09
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07613327055665DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055672DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055689DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055696DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055702DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055719DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055726DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055733DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055740DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055757DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055764DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055771DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055788DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055795DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327055801DRI-LOKSTRYKER CORPORATIONNBH2020-08-10
07613327054576Speed-LockSTRYKER CORPORATIONNBH2020-08-04
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07613327053043NASTRYKER CORPORATIONNBH2020-05-31
07613327053050NASTRYKER CORPORATIONNBH2020-05-31
07613327053081NASTRYKER CORPORATIONNBH2020-05-31
07613327052916NASTRYKER CORPORATIONNBH2020-05-20
07613327054569Speed-LockSTRYKER CORPORATIONNBH2020-04-28
07613327057751Speed-LockSTRYKER CORPORATIONNBH2020-04-28
07613327052930NASTRYKER CORPORATIONNBH2020-04-23
07613327052978NASTRYKER CORPORATIONNBH2020-04-23
07613327053036NASTRYKER CORPORATIONNBH2020-04-23