FDA.report

NORDENT MANUFACTURING INC

Primary DI
00840018657458
Brand
NORDENT MANUFACTURING INC
Company
NORDENT MANUFACTURING INC
Model
HKITHP
Device description
HAYES HYGIENE PROMO KIT
Published
2020-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FSMTray, Surgical, Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840018657458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840018657458008400186574588400186574580840018657458

GMDN Terms

TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods

Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
053187985
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840018674530Nordent Manufacturing, Inc. TCNSN137Nordent Hygiene Catalogue2026-03-14
00840018674547Nordent Manufacturing, Inc. OPPLN1-2Nordent Hygiene Catalogue2026-03-14
00840018674554Nordent Manufacturing, Inc. oppln3-4Nordent Hygiene Catalogue2026-03-14
00840018674561Nordent Manufacturing, Inc. OPPLN5-6Nordent Hygiene Catalogue2026-03-14
00840018674417Nordent Manufacturing, Inc. OPGN2Nordent Hygiene Catalogue2026-03-12
00840018674424Nordent Manufacturing, Inc. OPGN4Nordent Hygiene Catalogue2026-03-12
00840018674431Nordent Manufacturing, Inc. OPGN5-48Nordent Hygiene Catalogue2026-03-12
00840018674455Nordent Manufacturing, Inc. OPGNE128-128Nordent Hygiene Catalogue2026-03-12
00840018674462Nordent Manufacturing, Inc. OPGNMJNordent Hygiene Catalogue2026-03-12
00840018674479Nordent Manufacturing, Inc. OPGNMJTNordent Hygiene Catalogue2026-03-12
00840018674493Nordent Manufacturing, Inc. OPPM17S-18SNordent Hygiene Catalogue2026-03-12
00840018674509Nordent Manufacturing, Inc. OPPLN3-4MMNordent Hygiene Catalogue2026-03-12
00840018674516Nordent Manufacturing, Inc. PC11Q/6Nordent Instruments-Diagnostic2026-03-12
00840018674523Nordent Manufacturing, Inc. CV110/BG6Nordent Hygiene Catalogue2026-03-12
00840018674295Nordent Manufacturing, Inc. OPGGR11-12LNordent Hygiene Catalogue2026-03-11
00840018674301Nordent Manufacturing, Inc. OPGGR1-2Nordent Hygiene Catalogue2026-03-11
00840018674318Nordent Manufacturing, Inc. OPGGR1-2LNordent Hygiene Catalogue2026-03-11
00840018674325Nordent Manufacturing, Inc. OPGGR13-14Nordent Hygiene Catalogue2026-03-11
00840018674332Nordent Manufacturing, Inc. OPGGR13-14LNordent Hygiene Catalogue2026-03-11
00840018674349Nordent Manufacturing, Inc. OPGGR15-16Nordent Hygiene Catalogue2026-03-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07898663491562HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663493108HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663493467HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495263HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495270HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495751HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663496239HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663497267HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663498080HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663498097HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499292HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499926HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499957HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499971HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089802307HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089803113HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089803441HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089804349HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089804950HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089806367HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089806626HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089807012HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089807029HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089807999HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089808583HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089808682HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089808729HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089809511HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089809528HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089809535HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24