FDA.reportPublic FDA data

NA

Primary DI
04719880180400
Brand
NA
Company
HARITEX CORPORATION
Model
HC-52
Device description
FORCEPS THUMB WIRE W/SERRATED INST. 5" SINGLE USE
Published
2023-06-19
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
14719880180186PackageGS14In Commercial Distribution
04719880180189PrimaryGS10
04719880180400Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471988018018614719880180186
04719880180189047198801801894719880180189
04719880180400047198801804004719880180400

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 not intended for 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
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
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
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
00198506091230ELMED INCORPORATEDELMED INCORPORATEDGEN2026-06-03
G383S1061WM1413S3SURJEXSURJEXGEN2026-05-31
G383S1061WM3240913SURJEXSURJEXGEN2026-05-31
G383WM3241113SURJEXSURJEXGEN2026-05-31
00810055250929Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810055250936Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810055250943Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450264Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450271Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450288Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450295Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450301Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450318Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450325Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450332Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450349Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450356Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450363Surgical DesignSurgical Design, Inc.GEN2026-05-29
G043201100BEARBear-Ent, LLCGEN2026-04-17
G043201130BEARBear-Ent, LLCGEN2026-04-17
G043201140BEARBear-Ent, LLCGEN2026-04-17
G043201160BEARBear-Ent, LLCGEN2026-04-17
G043201190BEARBear-Ent, LLCGEN2026-04-17
G043201200BEARBear-Ent, LLCGEN2026-04-17
09348811008756INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009029INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009050INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009135INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811010155INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811151162INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19