FDA.reportPublic FDA data

Knot Manipulator Full Loop

Primary DI
10810128462423
Brand
Knot Manipulator Full Loop
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
301200frv
Catalog number
301200frv
Device description
Knot Manipulator Full Loop
Published
2025-09-14
Public version status
New
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810128462423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081012846242310810128462423

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

Regulatory Flags#

DUNS number
534123013
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10810128462997Champion+ Suture Passer3910-600-001382000st2026-04-07
10810128463000Champion+ Suture Passer 3910-600-002382100st2026-04-07
10810128463024Champion+ Suture Passer 3910-600-003S382300st2026-04-07
10810128463185Hip Bone Pick 60°512404t512404t2026-03-19
10810128463192Hip 2.5 Grasper393400t393400t2026-03-19

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