FDA.reportPublic FDA data

Custom Healthcare Systems, Inc.

Primary DI
00811870035036
Brand
Custom Healthcare Systems, Inc.
Company
Manus Medical, LLC
Model
DT-19714
Published
2020-04-09
Public version status
Update
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
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
20811870035030PackageGS110In Commercial Distribution
00811870035036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003503020811870035030
00811870035036008118700350368118700350360811870035036

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar puncture kitA collection of devices intended for transient percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to obtain a sample of cerebrospinal fluid (CSF). Typical components include a spinal needle and collection tubes for the CSF; a drainage catheter is not included. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
800604196
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
00811870037979Manus Medical, LLCZZ-0683-12024-02-06
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
00811870037948Manus Medical, LLCB9-18847-12024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160522332HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522349HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522356HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522363HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522370HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522394HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522400HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522448HalyardAVID MEDICAL, INC.LRO2026-06-02
10198956004887CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956245754CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956248908CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956312043CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956314634CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956314894CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956321717CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956356184CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956370760CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956376793CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956377363CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956384750CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956384873CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956385078CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956385160CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956391970CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956406193CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956439399CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956440685CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956444065CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956444850CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956445833CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01