FDA.reportPublic FDA data

Manus Medical, LLC

Primary DI
20811870037867
Brand
Manus Medical, LLC
Company
Manus Medical, LLC
Model
EMLP-20375-1
Device description
LUMBAR PUNCTURE KIT #2
Published
2023-12-20
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
OGJNerve Block Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGJNerve Block TrayAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870037867PackageGS110In Commercial Distribution
00811870037863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003786720811870037867
00811870037863008118700378638118700378630811870037863

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar puncture kitA collection of sterile devices designed to perform a puncture of the lumbar spine to obtain spinal fluid. Typical components include a spinal needle and collection tubes for spinal fluid. 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
true
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
10198956481176CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-06-05
10198956458451CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-06-01
10195327297756Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-13
10193489212969Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489215441Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489215885Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489217667Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489415827Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489422481Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489426816Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489428780Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489432077Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489432817Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489445497Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489447156Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489454994Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489810479Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
H65857032375Henry ScheinHENRY SCHEIN, INC.OGJ2022-12-13
10195327243142Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-11-24
H65857032195Henry ScheinHENRY SCHEIN, INC.OGJ2022-10-25
10193489848304Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-09-04
10193489415780Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-08-04
10193489417999Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-08-04
10193489432091Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-07-03
10193489403879Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-04-24
10193489216110Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-04-17
10193489452754Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-04-17
10193489457605Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-04-10
10195327022815Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-04-01
10195594502546CARDINAL HEALTHCardinal Health 200, LLCOGJ2022-02-26