FDA.reportPublic FDA data

Custom Healthcare Systems Inc.

Primary DI
00811870033254
Brand
Custom Healthcare Systems Inc.
Company
Manus Medical, LLC
Model
B9-17972
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
20811870033258PackageGS120In Commercial Distribution
00811870033254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003325820811870033258
00811870033254008118700332548118700332540811870033254

GMDN Terms#

Term, Definition table
TermDefinition
Mammographic stereotactic biopsy systemAn assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.

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
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
10198956323209CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956496101CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956531932CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956546035CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956548817CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956561335CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956575264CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956575905CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956577251CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956577657CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956584440CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956586161CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956586338CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956589179CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956589650CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956591080CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956591868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956593213CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956595460CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956596221CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956598744CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956600102CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956603059CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956605046CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956607118CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956607125CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956607958CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956608528CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956609815CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956609990CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29