FDA.reportPublic FDA data

Custom Healthcare Systems of VA, LLC

Primary DI
00811870035968
Brand
Custom Healthcare Systems of VA, LLC
Company
Manus Medical, LLC
Model
CPT5500
Published
2021-08-11
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
20811870035962PackageGS120In Commercial Distribution
00811870035968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003596220811870035962
00811870035968008118700359688118700359680811870035968

GMDN Terms#

Term, Definition table
TermDefinition
Suture kit, non-medicatedA collection of sterile instruments and dressings necessary to perform a suturing procedure; it does not contain any pharmaceuticals. It typically includes a disinfectant, needles and various threads (sutures used to join the edges of a wound or incision by stitching), drapes, swabs, needle holder, and other single-use disposable devices. This device may be used in a wide variety of clinical settings and some types may be used for the removal of sutures. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
800604196
Device count
1
DM 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
10809160537855HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537862HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537879HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537886HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537893HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537909HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537916HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537923HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537930HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537947HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537954HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537961HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537985HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537992HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538005HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538029HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538036HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538043HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537541HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537558HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537572HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537589HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537596HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537602HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537640HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537664HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537688HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537695HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537701HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537732HalyardAVID MEDICAL, INC.LRO2026-09-19