FDA.reportPublic FDA data

MULTICUTTER - Arthroscopic Retrograde Drill

Primary DI
07899258657677
Brand
MULTICUTTER - Arthroscopic Retrograde Drill
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
MULTICUTTER - Arthroscopic Retrograde Drill
Catalog number
312-500
Device description
Multicutter - Arthroscopic Retrograde Drill 322 x 36 x 23mm
Published
2024-01-19
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
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899258657677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258657677078992586576777899258657677

GMDN Terms#

Term, Definition table
TermDefinition
Ligament reconstruction instrument set, single-useA collection of surgical instruments intended to be used to prepare a joint for the reconstruction of damaged or torn ligaments, using a replacement device or tissue graft, during open or arthroscopic orthopaedic surgery. It typically consists of one or more guides, carriages, drill bits, reamers, burs, pushers, introducers, a staple impactor, and a surgical hammer. The set may be designed for specific joints, such as the shoulder or knee, and may assist in aligning the bone tunnels to allow isometric implantation of the ligament replacement device or graft. This is a single-use device.

Sterilization Methods#

Method table
Method

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
07899258696058Orthopedic Instruments180-1602026-09-29
07901125621138Orthopedic Instruments180-381-AO2026-09-29
07901125621145Orthopedic Instruments180-382-AO2026-09-29
07901125621312Orthopedic Instruments342-01152026-09-29
07901125621329Orthopedic Instruments342-01202026-09-29
07901125621336Orthopedic Instruments342-01542026-09-29
07901125621350Orthopedic Instruments180-ES-SP-02-FU2026-09-29
07901125621398Orthopedic Instruments352-1032026-09-29
07899258601670Orthopedic Instruments339-CX-262026-09-24
07901125621176Versalock Mini and Micro Plating System308-15-17-B-BL2026-09-18
07901125621183Versalock Mini and Micro Plating System308-15-19-B-BL2026-09-18
07901125621190Versalock Mini and Micro Plating System308-15-21-B-BL2026-09-18
07901125621206Versalock Mini and Micro Plating System308-15-23-B-BL2026-09-18
07899258654799Stitch - Suture Wires and Tapes333-239-AB1226CI2026-08-27
07899258654805Stitch - Suture Wires and Tapes333-239-PB1226CI2026-08-27
07899258654812Stitch - Suture Wires and Tapes333-20-B2026-08-27
07899258654829Stitch - Suture Wires and Tapes333-20-AB2026-08-27
07899258657141Stitch - Suture Wires and Tapes333-239-B1226CI2026-08-27
07899258665764Stitch - Suture Wires and Tapes333-536-AB1248CO2026-08-27
07899258665771Stitch - Suture Wires and Tapes333-536-B1248CO2026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867576070Arthrex®ARTHREX, INC.NBH2026-10-20
00888867576087Arthrex®ARTHREX, INC.NBH2026-10-20
00888867568280Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568297Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568303Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568310Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568457Arthrex®ARTHREX, INC.NBH2026-10-16
B382SD4830070Surgical DirectSurgical Direct, Inc.NBH2026-10-15
B382SD4840320Surgical DirectSurgical Direct, Inc.NBH2026-10-15
B382SD18146S90Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD316490Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD316690Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD316890Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD4810320Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD482014PH0Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD482036PH0Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD4843590Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD488200810Surgical DirectSurgical Direct, Inc.NBH2026-10-13
00888867620964Arthrex®ARTHREX, INC.NBH2026-10-12
00888867620971Arthrex®ARTHREX, INC.NBH2026-10-12
00888867620988Arthrex®ARTHREX, INC.NBH2026-10-12
00888867620995Arthrex®ARTHREX, INC.NBH2026-10-12
00190776434021MillenniumAvalign Technologies, Inc.NBH2026-10-09
00190776434106MillenniumAvalign Technologies, Inc.NBH2026-10-09
00190776433680MillenniumAvalign Technologies, Inc.NBH2026-10-07
00190776433123MillenniumAvalign Technologies, Inc.NBH2026-10-01
04055207071786NARichard Wolf GmbHNBH2026-10-01
04055207071830NARichard Wolf GmbHNBH2026-10-01
00190776431495MillenniumAvalign Technologies, Inc.NBH2026-09-22
00190776432119MillenniumAvalign Technologies, Inc.NBH2026-09-22