FDA.reportPublic FDA data

NA

Primary DI
04719880180165
Brand
NA
Company
HARITEX CORPORATION
Model
HC-41
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GDTStaple, Removable (Skin)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDTStaple, Removable (Skin)General, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719880180162PackageGS14In Commercial Distribution
04719880180165PrimaryGS10
04719880180387Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471988018016214719880180162
04719880180165047198801801654719880180165
04719880180387047198801803874719880180387

GMDN Terms#

Term, Definition table
TermDefinition
Skin staple remover, single-useA hand-held manual surgical instrument intended to be used to remove skin staples after the healing process has progressed sufficiently to permit the borders of the wound or incision to remain together without assistance. It is a tweezers-like device made of metallic or synthetic polymer materials with blades at the distal end activated by lever action designed for grasping, opening, and removing surgical staples. This is a single-use device.

Regulatory Flags#

DUNS number
656398765
Device count
250
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719880180530Haritex CorporationHC-33HC-332023-08-21
14719880180544Haritex CorporationHC-33HC-332023-08-21
04719880180516Haritex CorporationHC-57HC-572023-07-11
14719880180513Haritex CorporationHC-57HC-572023-07-11
04719880180141Haritex CorporationHC-312023-06-19
04719880180189NAHC-522023-06-19
04719880180219Haritex CorporationHC-13pbHC-13pb2023-06-19
04719880180226Haritex CorporationHC-33HC-332023-06-19
04719880180349Haritex CorporationHC-312023-06-19
04719880180400NAHC-522023-06-19
04719880180431Haritex CorporationHC-13pbHC-13pb2023-06-19
04719880180523Haritex CorporationHC-33HC-332023-06-19
04719880180493Haritex CorporationHC-43HC-432023-06-19
04719880180233NAHC-17HC-172023-05-30
14719880180230NAHC-172023-05-30
04719880180462NAHC-312022-12-05
04719880180011NAHC-112022-12-07
04719880180387NAHC-412022-12-07
04719880180028NAHC-112022-12-05
04719880180035NAHC-112022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00661392055148LSL HEALTHCARELSL Industries, LLCGDT2025-10-30
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20197344111050MEDLINEMEDLINE INDUSTRIES, INC.GDT2025-03-05
10080196846924Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GDT2025-02-16
40080196846925Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GDT2025-02-16
00192896120228Michel Wound ClipsSONTEC INSTRUMENTS, INC.GDT2024-10-15
14026704741943WECKTELEFLEX INCORPORATEDGDT2024-07-17
24026704741940WECKTELEFLEX INCORPORATEDGDT2024-07-17
04717480900374Taiwan SurgicalTAIWAN SURGICAL CORPORATIONGDT2023-08-02
04719880180493Haritex CorporationHARITEX CORPORATIONGDT2023-06-19
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00841767102947Trinity Sterile, Inc.Trinity Sterile, Inc.GDT2023-03-09
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