FDA.reportPublic FDA data

NA

Primary DI
14719880180469
Brand
NA
Company
HARITEX CORPORATION
Model
HC-31
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719880180469PackageGS14In Commercial Distribution
04719880180462PrimaryGS10
04719880180349Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471988018046914719880180469
04719880180462047198801804624719880180462
04719880180349047198801803494719880180349

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, tweezers-like, single-useA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656398765
Device count
1250
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
04719880180165NAHC-412022-12-07
04719880180387NAHC-412022-12-07
04719880180028NAHC-112022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776397050MillenniumAvalign Technologies, Inc.GEN2026-07-16
00190776398651MillenniumAvalign Technologies, Inc.GEN2026-07-16
B382SD914264010Surgical DirectSurgical Direct, Inc.GEN2026-07-13
00850083275075Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275082Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275099Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275105Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275112Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275129Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275136Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275143Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275280Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275310Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275334Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275358Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275440Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275471Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275495Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275600Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275723Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275846Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275938Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275976Intrace USAPILOTIS TECH LLCGEN2026-07-03
00860015282088Intrace USAPILOTIS TECH LLCGEN2026-07-03
00190776421656MillenniumAvalign Technologies, Inc.GEN2026-06-23
00810055258512Surgical DesignSurgical Design, Inc.GEN2026-06-22
00810055258543Surgical DesignSurgical Design, Inc.GEN2026-06-22
00810055258550Surgical DesignSurgical Design, Inc.GEN2026-06-22
00810055258567Surgical DesignSurgical Design, Inc.GEN2026-06-22
00810055258574Surgical DesignSurgical Design, Inc.GEN2026-06-22