FDA.reportPublic FDA data

45° Left, Champion®+ Slider with Nitinol Passing Wire

Primary DI
10810128461204
Brand
45° Left, Champion®+ Slider with Nitinol Passing Wire
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
3910-500-765
Catalog number
501300st
Published
2025-05-28
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
HWQPasser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWQPasserOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810128461204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081012846120410810128461204

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
10810128464311Hip 2.5 Grasper393400t393400t2026-03-19
10818674024324Hip Bone Pick 60°512404t512404t2026-03-19
10810128463918VersiTomic RR Retrograde Reamer 4.5 x 10.5mm0234-109-105145105st2026-08-03
10810128463925VersiTomic 2-Fluted Cannulated Reamer Ø5.0mm234-113-050124050st2026-08-03
10810128463932VersiTomic 2-Fluted Cannulated Reamer Ø5.5mm234-113-055124055st2026-08-03
10810128463949VersiTomic 2-Fluted Cannulated Reamer Ø6.0mm234-113-060124060st2026-08-03
10810128463956VersiTomic 2-Fluted Cannulated Reamer Ø6.5mm234-113-065124065st2026-08-03
10810128463963VersiTomic 2-Fluted Cannulated Reamer Ø7.0mm234-113-070124070st2026-08-03
10810128463970VersiTomic 2-Fluted Cannulated Reamer Ø7.5mm234-113-075124075st2026-08-03
10810128463987VersiTomic 2-Fluted Cannulated Reamer Ø8.0mm234-113-080124080st2026-08-03
10810128463994VersiTomic 2-Fluted Cannulated Reamer Ø8.5mm234-113-085124085st2026-08-03
10810128464007VersiTomic 2-Fluted Cannulated Reamer Ø9.0mm234-113-090124090st2026-08-03
10810128464014VersiTomic 2-Fluted Cannulated Reamer Ø9.5mm234-113-095124095st2026-08-03
10810128464021VersiTomic 2-Fluted Cannulated Reamer Ø10.0mm234-113-100124100st2026-08-03
10810128464038VersiTomic 2-Fluted Cannulated Reamer Ø10.5mm234-113-105124105st2026-08-03
10810128464045VersiTomic 2-Fluted Cannulated Reamer Ø11.0mm124110st234-113-1102026-08-03
10810128464052VersiTomic 2-Fluted Cannulated Reamer Ø12.0mm234-113-120124120st2026-08-03
10810128464069VersiTomic 2-Fluted Cannulated Reamer Ø13.0mm234-113-130124130st2026-08-03
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmAR-6593-57Q159o570ar2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmAR-6593-59Q159o590ar2026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421878MillenniumAvalign Technologies, Inc.HWQ2026-07-23
00190776421885MillenniumAvalign Technologies, Inc.HWQ2026-07-23
00816101010004Flexor Tendon Sheath Retractor and Suture Retriever / Sheath DilatorTOBY ORTHOPAEDICSHWQ2026-04-22
00190776419998MillenniumAvalign Technologies, Inc.HWQ2026-04-15
00190776420000MillenniumAvalign Technologies, Inc.HWQ2026-04-15
10818674022207Suture passeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2026-04-14
10850067560170LaproCloseSurgical Principals, IncHWQ2025-12-11
10850067560187LaproCloseSurgical Principals, IncHWQ2025-12-11
10850067560194LaproCloseSurgical Principals, IncHWQ2025-12-11
00850067560173LaproCloseSurgical Principals, IncHWQ2025-12-11
00850067560180LaproCloseSurgical Principals, IncHWQ2025-12-11
00850067560197LaproCloseSurgical Principals, IncHWQ2025-12-11
00842188130243Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130250Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130267Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130212Shuttle PinTrimed, INC.HWQ2025-07-08
00842188130229Shuttle PinTrimed, INC.HWQ2025-07-08
00842188130236Shuttle PinTrimed, INC.HWQ2025-07-08
00840277409935P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
00840277409942P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
00840277409959P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
10810128461075AC Slider NeedleT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846117425° Right, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846118125° Left, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846119845° Right, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846121190° Tight Curve, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
10810128461228Crescent, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
10810128461235Straight, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
04047844127964CYLOX STSIGNUS Medizintechnik GmbHHWQ2025-05-27
04047844127971CYLOX STSIGNUS Medizintechnik GmbHHWQ2025-05-27