FDA.reportPublic FDA data

Manus Medical, LLC

Primary DI
20811870037911
Brand
Manus Medical, LLC
Company
Manus Medical, LLC
Model
MMCUS1173
Device description
BONE MARROW BIOPSY TRAY
Published
2024-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OEZCardiovascular Procedure Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870037911PackageGS110In Commercial Distribution
00811870037917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003791120811870037911
00811870037917008118700379178118700379170811870037917

GMDN Terms#

Term, Definition table
TermDefinition
Bone marrow biopsy procedure kitA packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. 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
10809160527757HalyardAVID MEDICAL, INC.OEZ2026-07-23
00884450376546Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-22
00884450488751Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-22
00884450499276Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-22
10809160527719HalyardAVID MEDICAL, INC.OEZ2026-07-22
10809160527658HalyardAVID MEDICAL, INC.OEZ2026-07-21
10197106917619CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956119505CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956173552CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956326583CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956343337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956346758CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956427723CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956439375CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956462045CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956487666CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956490031CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956492967CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956493742CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956496248CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956496439CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956500259CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956502673CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956504912CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956509665CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956510463CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956512894CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956514942CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956515369CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956516359CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20