FDA.reportPublic FDA data

Suture Passer

Primary DI
07899258662657
Brand
Suture Passer
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
Suture Transporter
Catalog number
312-200
Device description
Suture Passer - Suture Transporter
Published
2024-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
07899258662657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258662657078992586626577899258662657

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.

Regulatory Flags#

DUNS number
900865213
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
07899258606637Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x10.0mm169-35-102026-07-30
07899258606644Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x12.0mm169-35-122026-07-30
07899258606651Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x14.0mm169-35-142026-07-30
07899258606668Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x16.0mm169-35-162026-07-30
07899258606675Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x18.0mm169-35-182026-07-30
07899258606682Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x20.0mm169-35-202026-07-30
07899258606699Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x22.0mm169-35-222026-07-30
07899258606705Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x24.0mm169-35-242026-07-30
07899258606712Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x26.0mm169-35-262026-07-30
07899258606729Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x28.0mm169-35-282026-07-30
07899258606736Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x30.0mm169-35-302026-07-30
07899258606743Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x32.0mm169-35-322026-07-30
07899258606750Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x34.0mm169-35-342026-07-30
07899258606767Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x35.0mm169-35-352026-07-30
07899258606774Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x36.0mm169-35-362026-07-30
07899258606781Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x38.0mm169-35-382026-07-30
07899258606798Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x40.0mm169-35-402026-07-30
07899258606804Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x42.0mm169-35-422026-07-30
07899258606811Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x44.0mm169-35-442026-07-30
07899258606828Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x45.0mm169-35-452026-07-30

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
1081012846120445° Left, 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