FDA.reportPublic FDA data

Nitinol Loop Passer MEDACTA

Primary DI
10810128462645
Brand
Nitinol Loop Passer MEDACTA
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
05.06.10.0022
Catalog number
146000md
Published
2026-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HXIPasser, Wire, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXIPasser, Wire, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810128462645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081012846264510810128462645

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, single-useA 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 single-use 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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810128462782StayPort™ Cannula 5 mm x 7 cmAR-6593-05-07159570ar2026-07-16
10810128462799StayPort™ Cannula 5 mm x 9 cmAR-6593-05-09159590ar2026-07-16
10810128462805StayPort™ Cannula 7 mm x 7 cmAR-6593-07-07159770ar2026-07-16
10810128462812StayPort™ Cannula 7 mm x 9 cmAR-6593-07-09159790ar2026-07-16
10810128462829StayPort™ Cannula 9 mm x 7 cmAR-6593-09-07159970ar2026-07-16
10810128462836StayPort™ Cannula 9 mm x 9 cmAR-6593-09-09159990ar2026-07-16
10810128462843StayPort™ Cannula 9 mm x 11 cmAR-6593-09-11159110ar2026-07-16
10810128462850StayPort™ Cannula 9 mm x 13 cmAR-6593-09-13159130ar2026-07-16
10810128462867VersiTILT 2.4 x 8.5mm Implant System3910-700-010505100st2026-07-16
10810128462874VersiTILT 2.4 x 8.5mm Button and Inserter3910-700-011505101st2026-07-16
10810128462881VersiTILT Drill Pin, 3.1mm3910-700-012505102st2026-07-16
10810128462898VersiTILT Button, 2.4x8.5mm3910-700-013505103st2026-07-16
10810128462904VersiTILT 2.4x12mm Implant System, Long3910-700-020505200st2026-07-16
10810128462911VersiTILT 2.4x12mm Button and Inserter, Long3910-700-021505201st2026-07-16
10810128462928VersiTILT Button, 2.4x12mm3910-700-023505203st2026-07-16
10810128462935VersiTILT 3.1x10.9mm Implant System, XL3910-700-030505300st2026-07-16
10810128462942VersiTILT 3.1x10.9mm Button and Inserter, XL3910-700-031505301st2026-07-16
10810128462959VersiTILT Drill Pin, 3.6mm3910-700-032505302st2026-07-16
10810128462966VersiTILT Button, 3.1x10.9mm3910-700-033505303st2026-07-16
10818674027097FiberStitch™ Implant 1.5, Curved with two Polyester Implants and 2-0 FiberWire®AR-4580176200ar2023-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731135568TITANEX VILEX LLCHXI2026-05-15
00841731137319TITANEX VILEX LLCHXI2026-05-15
00841731137906TITANEXVILEX LLCHXI2026-05-15
00841731138095TITANEX VILEX LLCHXI2026-05-15
00841731142870TITANEX VILEX LLCHXI2026-05-15
00841731142887TITANEX VILEX LLCHXI2026-05-15
00841731146717TITANEXVILEX LLCHXI2026-05-15
00841731146724TITANEXVILEX LLCHXI2026-05-15
00841731146731TITANEXVILEX LLCHXI2026-05-15
00841731147141TITANEX VILEX LLCHXI2026-05-15
00889795152671Monkey Rings™ External Fixation SystemParagon 28, Inc.HXI2026-05-06
00889795152688Monkey Rings™ External Fixation SystemParagon 28, Inc.HXI2026-05-06
00889795152695Monkey Rings™ External Fixation SystemParagon 28, Inc.HXI2026-05-06
B8034803860ORTHOMEDORTHO-MED, INC.HXI2026-04-16
B8034803880ORTHOMEDORTHO-MED, INC.HXI2026-04-16
00840311246830Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HXI2026-03-18
00841731134769Hintermann Series VILEX LLCHXI2026-01-16
06974940306369endophixSuzhou Endophix Co., Ltd.HXI2025-12-12
06974940306147endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306154endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306161endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306178endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306185endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306192endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306208endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306215endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306222endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306239endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306246endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306253endophixSuzhou Endophix Co., Ltd.HXI2025-12-05