FDA.reportPublic FDA data

Custom Healthcare Systems Inc.

Primary DI
00811870030222
Brand
Custom Healthcare Systems Inc.
Company
Manus Medical, LLC
Model
D33-8608
Published
2018-07-26
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
KIZDish, Tissue Culture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIZDish, Tissue CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870030226PackageGS1100In Commercial Distribution
00811870030222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003022620811870030226
00811870030222008118700302228118700302220811870030222

GMDN Terms#

Term, Definition table
TermDefinition
Wound dressing kit, medicatedA collection of instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. 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
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
10194484321731N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KIZ2025-08-11
00194484321734N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KIZ2025-08-11
10194484321236N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KIZ2025-08-08
10194484321243N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KIZ2025-08-08
00194484321239N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KIZ2025-08-08
00194484321246N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KIZ2025-08-08
00840117331099LabChoice Petri Dishes, Stackable, 90 x 15 mm, Sterile Dynarex CorporationKIZ2025-06-16
00840117331105LabChoice Petri Dishes, Stackable, Sterile, 150 x 15 mm Dynarex CorporationKIZ2025-06-16
00810180842198LabChoice Petri Dishes, Stackable, 90 x 15 mm, Sterile Dynarex CorporationKIZ2025-06-16
00810180842204LabChoice Petri Dishes, Stackable, Sterile, 150 x 15 mm Dynarex CorporationKIZ2025-06-16
00850043803041Planet-Safe®Diversified Biotech, Inc.KIZ2024-10-07
00850043803058Planet-Safe®Diversified Biotech, Inc.KIZ2024-10-07
00850043803065Planet-Safe®Diversified Biotech, Inc.KIZ2024-10-07
00850043803072Planet-Safe®Diversified Biotech, Inc.KIZ2024-10-07
00850043803089Planet-Safe®Diversified Biotech, Inc.KIZ2024-10-07
00850043803096Planet-Safe®Diversified Biotech, Inc.KIZ2024-10-07
00630094176512Bioseal Inc.BIOSEALKIZ2023-10-02
00630094765112Bioseal Inc.BIOSEALKIZ2023-10-02
10630094176519Bioseal Inc.BIOSEALKIZ2023-10-02
10630094765119Bioseal Inc.BIOSEALKIZ2023-10-02
00630094172408Bioseal Inc.BIOSEALKIZ2023-09-18
00630094172439Bioseal Inc.BIOSEALKIZ2023-09-18
00630094172507Bioseal Inc.BIOSEALKIZ2023-09-18
10630094172405Bioseal Inc.BIOSEALKIZ2023-09-18
10630094172436Bioseal Inc.BIOSEALKIZ2023-09-18
10630094172504Bioseal Inc.BIOSEALKIZ2023-09-18
00850043803010Planet-Safe®Diversified Biotech, Inc.KIZ2023-07-15
00850043803027Planet-Safe®Diversified Biotech, Inc.KIZ2023-07-15
06974669350292MDHCMDHC Life Technologies (Kunshan) Co., LTD.KIZ2023-07-06
14039943000849CELLMASTERGreiner Bio - One GmbHKIZ2023-04-01