FDA.reportPublic FDA data

Champion+ Suture Passer

Primary DI
10810128462997
Brand
Champion+ Suture Passer
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
3910-600-001
Catalog number
382000st
Device description
Champion+ Suture Passer with Ratcheting Handle
Published
2026-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10810128462997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081012846299710810128462997

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, reusableA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
534123013
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
10818674027097FiberStitch™ Implant 1.5, Curved with two Polyester Implants and 2-0 FiberWire®AR-4580176200ar2023-09-27
10818674027103FiberStitch™ Implant 1.5, Straight with two Polyester Implants and 2-0 FiberWireAR-4580S176100ar2023-09-27
10818674027110FiberStitch™ Implant 1.5, Reverse Curved with two Polyester Implants and 2-0 FibAR-4580R176300ar2023-09-27
10818674027127FiberStitch™ Implant 1.5, 24° Curved with two Polyester Implants and 2-0 FiberWiAR-4580-24176400ar2023-09-27
10818674021545Switchcut Femoral Guide Arm Point110026880148400bsm2026-05-18
10818674021552Switchcut Tibial Guide Arm PCL110026881148500bsm2026-05-18
10810128463291Back Drill Guide Bullet ID 4.5mmS25-3001-T149000su2026-05-13
10810128463307Back Drill Guide Bullet ID 6.0mmS25-3002-T150000su2026-05-13
10810128463574Rasp Up Bend 20°S36-0013-T901131su2026-05-13
10810128463581Rasp Down Bend 20°S36-0024-T901141su2026-05-13
108101284636284.5mm Can. Full Thickness DrillS250045A113045su2026-05-13
108101284636357.0mm Can. Full Thickness DrillS25-7000-AT113070su2026-05-13
108101284636428.0mm Can. Full Thickness DrillS25-8000-AT113080su2026-05-13
108101284636599.0mm Can. Full Thickness DrillS25-9000-AT113090su2026-05-13
10810128463666Back Drill Femoral Guide Arm RightS25-3200-T148200su2026-05-13
10810128463673Back Drill Tibial Guide to PointS25-3300-T148300su2026-05-13
10810128463697Meniscal Root ArmS25-3600-T148600su2026-05-13
10810128462775OsteoTak ArthrexAR-1902611018ar2026-05-05
10818674022207Suture passe110038984254001bsm2026-04-14
10810128463000Champion+ Suture Passer 3910-600-002382100st2026-04-07

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