FDA.reportPublic FDA data

"Mayo-Hegar Needle Holders BJ 14cm/5 1/2"""

Primary DI
G2021906342140
Brand
"Mayo-Hegar Needle Holders BJ 14cm/5 1/2"""
Company
CONCISE ENTERPRISES
Model
190634214
Catalog number
19-06342-14
Device description
The Mayo-Hegar Needle Holder is a surgical instrument designed for holding and driving needles during suturing procedures.
Published
2023-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
G2021906342140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, single-useA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and 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. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
645816062
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G2021401794160Mayo Noble 16cm14017941614-01794-162023-12-08
G2021402629160Lister Scissor 16cm14026291614-02629-162023-12-08
G2021402785090Nail Scissor Curved 14027850914-02785-092023-12-08
G2021401694140Surgical Scissor14016941414-01694-142023-12-04
G2022408052140Jacobson Combination Spoon24080521424-08052-142023-12-04
G2021906342130Mayo Hegar Needle Holder 13cm19063421319-06342-132023-07-16
G2021906342180Mayo Hegar Needle Holder 18cm19063421819-06342-182023-07-16
G202210703820Volkmann double Curette 22cm21070382021-07038-202023-07-16
G2022107040200Volkmann double Curette 22cm oval/round21070402021-07040-202023-07-16
G2021604294120Mosquito Forceps straight 12,5cm16042941216-04294-122023-06-15
G2021604295120Mosquito Forceps curved 12,5cm16042951216-04295-122023-06-14
G202150402614Lane Dressing forceps 1x2 teeth, 12,5cm15040261415-04026-142023-04-19
G2021503024120Adson Forceps tissue 1x2 teeth 12,5cm15030241215-03024-122023-04-15
G2021502830120Adson Forceps fine 12cm15028301215-02830-122023-04-06
G2021502834120Adson Forceps 12,5cm15028341215-02834-122023-04-06
G2021503046150Gillies Dressing forceps 1x2teeth 15cm15030461515-03046-152023-05-06
G2021502952100Dressing Tissue Forcep 1x2 teeth with pin 10cm15029521015-02952-102023-04-15
G2021502806150Dissecting Forceps Fine 15cm15028061515-02806-152023-04-08
G20219063421416Mayo Hegar Needle Holder19063421419-06342-142023-04-08
G20224080521412Jacobson Combination Spoon24080521424-08052-142023-04-07

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