Custom Healthcare Systems

Primary DI
00811870030048
Brand
Custom Healthcare Systems
Company
Manus Medical, LLC
Model
B8-10359
Published
2018-07-31
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
20811870030042PackageGS120In Commercial Distribution
00811870030048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003004220811870030042
00811870030048008118700300488118700300480811870030048

GMDN Terms#

Term, Definition table
TermDefinition
Surgical preparation kitA collection of sterile devices designed for the preoperative preparation of the operative site on a patient's body. It typically includes scrubbing pads (e.g., surgical sponges) and sterilizing/disinfecting solutions. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
800604196
Device count
1
Premarket exempt
true
Kit
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H65857029125Henry ScheinHENRY SCHEIN, INC.LRO2022-02-09
H65857029135Henry ScheinHENRY SCHEIN, INC.LRO2022-02-09
H65857029145Henry ScheinHENRY SCHEIN, INC.LRO2022-02-09
H65857029165Henry ScheinHENRY SCHEIN, INC.LRO2022-02-09
H65857029105Henry ScheinHENRY SCHEIN, INC.LRO2022-02-08
H65857029115Henry ScheinHENRY SCHEIN, INC.LRO2022-02-08
H65857029095Henry ScheinHENRY SCHEIN, INC.LRO2022-02-04
H65857029005Henry ScheinHENRY SCHEIN, INC.LRO2022-01-31
H65857028265Henry ScheinHENRY SCHEIN, INC.LRO2022-01-28
H65857028255Henry ScheinHENRY SCHEIN, INC.LRO2022-01-27
H65857028285Henry ScheinHENRY SCHEIN, INC.LRO2022-01-27
H65857029045Henry ScheinHENRY SCHEIN, INC.LRO2022-01-27
H65857029055Henry ScheinHENRY SCHEIN, INC.LRO2022-01-27
H65857029065Henry ScheinHENRY SCHEIN, INC.LRO2022-01-27
H65857029075Henry ScheinHENRY SCHEIN, INC.LRO2022-01-27
H65857029085Henry ScheinHENRY SCHEIN, INC.LRO2022-01-27
H65857028925Henry ScheinHENRY SCHEIN, INC.LRO2022-01-26
H65857028935Henry ScheinHENRY SCHEIN, INC.LRO2022-01-25
H65857028945Henry ScheinHENRY SCHEIN, INC.LRO2022-01-25
H65857028915Henry ScheinHENRY SCHEIN, INC.LRO2022-01-24
H65857028965Henry ScheinHENRY SCHEIN, INC.LRO2022-01-24
H65857028975Henry ScheinHENRY SCHEIN, INC.LRO2022-01-24
H65857028985Henry ScheinHENRY SCHEIN, INC.LRO2022-01-24
H65857028995Henry ScheinHENRY SCHEIN, INC.LRO2022-01-24
H65857029015Henry ScheinHENRY SCHEIN, INC.LRO2022-01-24
H65857028905Henry ScheinHENRY SCHEIN, INC.LRO2022-01-18
H65857028875Henry ScheinHENRY SCHEIN, INC.LRO2021-12-29
H65857028865Henry ScheinHENRY SCHEIN, INC.LRO2021-12-21
H65857028855Henry ScheinHENRY SCHEIN, INC.LRO2021-12-14
H65857028845Henry ScheinHENRY SCHEIN, INC.LRO2021-12-13