FDA.reportPublic FDA data

NORDENT MANUFACTURING INC

Primary DI
00840018645875
Brand
NORDENT MANUFACTURING INC
Company
NORDENT MANUFACTURING INC
Model
NH204
Device description
NHDLR SST #204 (6/150MM)
Published
2020-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FHQHolder, Needle, Gastroenterologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840018645875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840018645875008400186458758400186458750840018645875

GMDN Terms#

Term, Definition table
TermDefinition
Needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
053187985
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840018674646SabraNAB2/6Nordent Diagnostic Cataloge2026-05-12
00840018674653Nordent Manufacturing, Inc. TCNSGRA13-14Nordent Hygiene Catalogue2026-05-12
00840018674622Nordent Manufacturing, Inc. BUR2892Nordent Restorative Catalouge2026-05-05
00840018674639Nordent Manufacturing, Inc. RFPH9-10Nordent Surgical Catalog2026-05-05
00008418674554Nordent Manufacturing, Inc. OPPLN3-4Nordent Hygiene Catalogue2026-04-10
00840018674578Nordent Manufacturing, Inc. CENSN128Nordent Hygiene Catalogue2026-04-10
00840018674585Nordent Manufacturing, Inc. SGR17-18/BG6Nordent Hygiene Catalogue2026-04-10
00840018674592Nordent Manufacturing, Inc. N113/BG6Nordent Restorative Catalouge2026-04-10
00840018674608Nordent Manufacturing, Inc. SCA204-4Nordent Hygiene Catalogue2026-04-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840319759424Hayden MedicalHayden Medical, Inc.FHQ2026-09-04
00190776419684MillenniumAvalign Technologies, Inc.FHQ2026-08-25
00850083997007Suture SheildSUTURE SHIELD, INC.FHQ2026-08-03
B382SD45267180Surgical DirectSurgical Direct, Inc.FHQ2026-08-03
B382SD90557818E0Surgical DirectSurgical Direct, Inc.FHQ2026-07-29
00810143905076SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143905083SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143905106SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143907193SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143908671SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143908701SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909081SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909753SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909760SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212931517SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212931678SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934709SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934716SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934723SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934921SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934938SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934945SURGIPROSSurgipros, LLCFHQ2026-07-28
B382SD9056791110Surgical DirectSurgical Direct, Inc.FHQ2026-07-28
B382SD905701100Surgical DirectSurgical Direct, Inc.FHQ2026-07-23
00840183531980BR Surgical, LLCBR Surgical, LLCFHQ2026-07-22
00190776403751MillenniumAvalign Technologies, Inc.FHQ2026-07-21
00840183531720BR Surgical, LLCBR Surgical, LLCFHQ2026-07-21
00840183532475BR Surgical, LLCBR Surgical, LLCFHQ2026-07-21
00840183532499BR Surgical, LLCBR Surgical, LLCFHQ2026-07-21
00190776397104MillenniumAvalign Technologies, Inc.FHQ2026-07-16