FDA.reportPublic FDA data

Manus Medical, LLC

Primary DI
20811870037904
Brand
Manus Medical, LLC
Company
Manus Medical, LLC
Model
LPGM-002-1
Device description
LIPOGEMS EFFICIENCY KIT TAA
Published
2024-02-02
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
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870037904PackageGS18In Commercial Distribution
00811870037900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003790420811870037904
00811870037900008118700379008118700379000811870037900

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. 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
true
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
05060267134547FORCECORDXIROS LTDOJH2026-07-06
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10198956407053CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956414693CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956428881CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956429901CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956457775CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956474895CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956481015CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956484177CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956490833CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956491038CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956492158CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956492196CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956494572CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956494695CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956497498CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956498426CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956498471CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956499775CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956503199CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956503298CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956508798CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956509368CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956512962CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956513921CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956516571CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956518018CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956525597CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06