FDA.reportPublic FDA data

Custom Healthcare Systems Inc.

Primary DI
00811870031038
Brand
Custom Healthcare Systems Inc.
Company
Manus Medical, LLC
Model
R1186 / 12880
Published
2018-07-29
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
KJGTube, Tissue Culture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJGTube, Tissue CulturePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870031032PackageGS150In Commercial Distribution
00811870031038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003103220811870031032
00811870031038008118700310388118700310380811870031038

GMDN Terms#

Term, Definition table
TermDefinition
Surgical patient preparation kitA collection of 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
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

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