FDA.reportPublic FDA data

Haritex Corporation

Primary DI
14719880180513
Brand
Haritex Corporation
Company
HARITEX CORPORATION
Model
HC-57
Catalog number
HC-57
Device description
FORCEPS WIRE HEMO KELLY STR 5-1/2", SINGLE USE.
Published
2023-07-11
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
HRQHemostat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRQHemostatGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719880180513PackageGS14In Commercial Distribution
04719880180516PrimaryGS10
04719880180509Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471988018051314719880180513
04719880180516047198801805164719880180516
04719880180509047198801805094719880180509

GMDN Terms#

Term, Definition table
TermDefinition
Medical tubing clip/clamp, temporary, non-calibrated, single-useA manual device designed to compress a piece of medical device tubing or tubular container to reversibly occlude its lumen and stop the flow of material within; it is not intended for patient-contact. It has a manual mechanism (e.g., hinging, roller-type, vice-like) whereby pressure on the tube can be applied or removed, however it is not a calibrated device (e.g., it is often a roller type, clip, or screw-clamp). It may be referred to as a clip or a clamp. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656398765
Device count
250
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
true
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
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
04719880180035NAHC-112022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810212931128SURGIPROSSurgipros, LLCHRQ2026-06-01
00810212931135SURGIPROSSurgipros, LLCHRQ2026-06-01
00810212931142SURGIPROSSurgipros, LLCHRQ2026-06-01
00810212931166SURGIPROSSurgipros, LLCHRQ2026-06-01
00810212931173SURGIPROSSurgipros, LLCHRQ2026-06-01
00810055250684Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055250691Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055250707Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055250714Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259687Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259694Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259700Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259717Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259724Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259731Surgical DesignSurgical Design, Inc.HRQ2026-05-27
10193489456325Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HRQ2022-08-04
ESAM3800121STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3800141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3805121STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3805141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3815121STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3815141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3826141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3827141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3839141STOMA®Storz am Mark GmbHHRQ2020-08-27
10381780361022Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-07-27
10381780361039Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-07-27
10381780361046Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-07-27
10381780385998Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-05-02
10381780024958Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-04-03