FDA.reportPublic FDA data

Manus Medical, LLC

Primary DI
20811870037898
Brand
Manus Medical, LLC
Company
Manus Medical, LLC
Model
COMBO-17891-1
Device description
Combo Tray 1 & 2
Published
2024-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870037898PackageGS130In Commercial Distribution
00811870037894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003789820811870037898
00811870037894008118700378948118700378940811870037894

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
800604196
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811870037979Manus Medical, LLCZZ-0683-12024-02-06
00811870033216Custom Healthcare Systems Inc.UNC-179142018-07-25
00811870035555Custom Healthcare Systems of VA, LLCCLT-199142021-06-18
00811870030703Custom Healthcare Systems Inc.VBS-18520C2018-10-19
00811870032943CUSTOM HEALTHCARE SYSTEMS, INCDT-0520192019-06-03
00811870034411Custom Healthcare Systems Inc.VBS-18520B2018-10-19
00811870035036Custom Healthcare Systems, Inc.DT-197142020-04-09
00811870035166Custom Healthcare Systems, Inc.CUS1365-022020-07-28
00811870035630Custom Healthcare Systems of VA, LLCDT-19714 v22021-07-12
00811870035661Custom Healthcare Systems of VA, LLCDT-193432021-07-15
00811870035883Custom Healthcare Systems Inc.VBS-191082019-03-07
00811870035890Custom Healthcare Systems Inc.11168030152019-03-07
00811870037863Manus Medical, LLCEMLP-20375-12023-12-20
00811870037986Manus Medical, LLCUNC-9800-02024-02-07
20811870037980Manus Medical, LLCUNC-9800-02024-02-07
20811870037973Manus Medical, LLCZZ-0683-12024-02-06
00811870037887Manus Medical, LLCLPGM-0012024-02-02
00811870037900Manus Medical, LLCLPGM-002-12024-02-02
00811870037917Manus Medical, LLCMMCUS11732024-02-02
00811870037924Manus Medical, LLCA2081V-72024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS17798A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS179150Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190180Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190730Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190920Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190930Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS194550Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS195260Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS13932C0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS16019B0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS17843A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS18256A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS187260Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS5861D0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
10809160527825HalyardAVID MEDICAL, INC.LRO2026-07-24
10809160527788HalyardAVID MEDICAL, INC.LRO2026-07-23
10809160527801HalyardAVID MEDICAL, INC.LRO2026-07-23
10809160527818HalyardAVID MEDICAL, INC.LRO2026-07-23
10809160527726HalyardAVID MEDICAL, INC.LRO2026-07-22
10809160527733HalyardAVID MEDICAL, INC.LRO2026-07-22
10809160527740HalyardAVID MEDICAL, INC.LRO2026-07-22
B098AMS15343A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
B098AMS174900Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
B098AMS187270Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
10653160394068CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-07-21
10653160394105MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394150MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394167MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394174MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394266MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21