FDA.reportPublic FDA data

Parcus Instrumentation

Primary DI
00816342020718
Brand
Parcus Instrumentation
Company
PARCUS MEDICAL LLC
Model
10107
Device description
Graft Station Tray (20019)
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KQZComponent, Traction, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQZComponent, Traction, Non-InvasiveOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816342020718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816342020718008163420207188163420207180816342020718

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament graft preparation stationAn assembly of devices designed to provide the operator with a workstation for the preparation and pretensioning of a ligament and/or tendon graft prior to implantation. It typically consists of a work base to provide a stable platform on which the graft can be treated, various types of adjustable and fixed posts including soft tissue clamps and tensioning devices, a graft sizing block, and tools to hold and tension a graft (e.g., an Allen key). It may be used for a variety of bone-tendon-bone and soft tissue grafts such as semitendinosus patellar tendon, quadriceps tendon, or patellar tendon grafts for anterior cruciate ligament (ACL) reconstruction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
859961950
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816342022491X-Twist BiocompositeXT447002025-04-29
00816342025447X-Twist BiocompositeXT447012025-04-29
00816342025454X-Twist BiocompositeXT447022025-04-29
00816342025461X-Twist BiocompositeXT447032025-04-29
00816342025478X-Twist BiocompositeXT455002025-04-29
00816342025485X-Twist BiocompositeXT455012025-04-29
00816342025492X-Twist BiocompositeXT455022025-04-29
00816342025508X-Twist BiocompositeXT455032025-04-29
00816342025515X-Twist BiocompositeXT462002025-04-29
00816342025539ProPass202552025-04-29
00816342025546ProPass202562025-04-29
00816342025553ProPass116792025-04-29
00816342023573Parcus Instrumentation11019U2023-07-29
00816342023580Parcus Instrumentation10873U2023-07-29
00816342023634Parcus Instrumentation10482U2023-07-29
00816342023658Parcus Instrumentation10874U2023-07-29
00816342023726Parcus Instrumentation200982023-07-29
00816342023740Parcus Instrumentation10615HU2023-07-29
00816342023795Knotless Push-In Suture Anchor109942023-07-29
00816342023931Twist PEEK Suture Anchor110032023-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888867484983Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485096Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485102Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485119Arthrex®ARTHREX, INC.KQZ2025-12-10
00810075281514BoneFoamBONE FOAM, INC.KQZ2025-08-15
10888867502717Arthrex®ARTHREX, INC.KQZ2025-08-14
20845854082925ParadigmConmed CorporationKQZ2023-06-13
20845854082932ParadigmConmed CorporationKQZ2023-06-13
2078755101165890403 Shoulder Arthroscopy KitXODUS MEDICAL, INC.KQZ2022-12-08
20787551011672NS90403 Shoulder Suspension KitXODUS MEDICAL, INC.KQZ2022-12-08
00842331141027Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-11
00842331143373Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-11
00842331136627Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-10
00610570001712100 FT. 3/16" TRACTION CORDBird & Cronin, LLCKQZ2022-08-20
006105700017501500 FT. 3/16" TRACTION CORDBird & Cronin, LLCKQZ2022-08-20
00610570006588BUCKS BOOT XSBird & Cronin, LLCKQZ2022-08-20
00610570006595BUCKS BOOT SMBird & Cronin, LLCKQZ2022-08-20
00610570006601BUCKS BOOT MDBird & Cronin, LLCKQZ2022-08-20
00610570006618BUCKS BOOT LGBird & Cronin, LLCKQZ2022-08-20
00610570006649BUCKS BOOT UNIV CLSD-COMPLETEBird & Cronin, LLCKQZ2022-08-20
00610570006656DISPOSABLE PAD-UNIVERSAL BOOTBird & Cronin, LLCKQZ2022-08-20
00610570006663SADDLE FOR UNIV BUCKS TRACTIONBird & Cronin, LLCKQZ2022-08-20
00610570011810DISKARD HEAD HALTERBird & Cronin, LLCKQZ2022-08-20
00610570011858DELUXE HEAD HALTER UNIV BLACKBird & Cronin, LLCKQZ2022-08-20
00610570012503SPREADER BAR 12" NOTCHEDBird & Cronin, LLCKQZ2022-08-20
0061057001260220# WATER WEIGHT BAGBird & Cronin, LLCKQZ2022-08-20
00610570068951EXERCISE BAND ANCHOR STRAPS 10/PKBird & Cronin, LLCKQZ2022-08-20
07290015711302D.B.S. Dynamic Brace SystemMEDITRAC LTD.KQZ2022-07-25
00810075280784Bone FoamBONE FOAM, INC.KQZ2022-05-22
00810075281194Bone FoamBONE FOAM, INC.KQZ2022-05-22