FDA.reportPublic FDA data

V-Guide

Primary DI
08800142924026
Brand
V-Guide
Company
RF Medical Co.,Ltd.
Model
VG2002
Published
2023-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HDQDilator, Cervical, Fixed Size

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDQDilator, Cervical, Fixed SizeObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800142924026PackageGS110In Commercial Distribution
08800142924033PackageGS120In Commercial Distribution
08800142924019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800142924026088001429240268800142924026
08800142924033088001429240338800142924033
08800142924019088001429240198800142924019

GMDN Terms#

Term, Definition table
TermDefinition
Needle guide, single-useA rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690514869
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
08800142906435BIG-TIP™BT 1030OB2025-09-05
08800142906442BIG-TIP™BT 1035OB2025-09-05
08800142906459BIG-TIP™BT 1040OB2025-09-05
08800142906534BIG-TIP™BT+1505B2025-09-05
08800142906541BIG-TIP™BT+ 2005B2025-09-05
08800142906558BIG-TIP™BT+ 2010B2025-09-05
08800142906565BIG-TIP™BT+ 2015B2025-09-05
08800142906572BIG-TIP™BT+ 2505B2025-09-05
08800142906886BIG-TIP™CWT 3505B2025-09-05
08800142906893BIG-TIP™CWT 3535B2025-09-05
08800142906909BIG-TIP™CWT 3540B2025-09-05
08800142907005BIG-TIP™CWT 3505RB2025-09-05
08800142907012BIG-TIP™CWT 3535RB2025-09-05
08800142907029BIG-TIP™CWT 3540RB2025-09-05
08800142909672BIG-TIP™JET 1020B2025-09-05
08800142909689JET-TIP®JET 1025B2025-09-05
08800142909719JET-TIP®JET 1505B2025-09-05
08800142909726JET-TIP®JET 2005B2025-09-05
08800142909733JET-TIP®JET 1505QB2025-09-05
08800142909740JET-TIP®JET 1510QB2025-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719894432434BiotequeBioteque Taiwan Ltd.HDQ2024-04-08
04719894432441BiotequeBioteque Taiwan Ltd.HDQ2024-04-08
04719894432458BiotequeBioteque Taiwan Ltd.HDQ2024-04-08
G586NSGU40600160Novo SurgicalNOVO SURGICAL, INC.HDQ2024-03-08
GYNX42111GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42121GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42131GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42211GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42221GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42231GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42401GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42451GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42501GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42551GynexGYNEX CORPORATIONHDQ2023-12-19
08800142923982V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924019V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924040V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924071V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924101V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924132V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
07898506815050QuinelatoSchobell Industrial LtdaHDQ2023-01-09
07899798202634SchobellSchobell Industrial LtdaHDQ2023-01-09
10653160314332CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDQ2022-01-01
10381780509363Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-10-23
10381780509370Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-10-23
10381780500728Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
10381780500735Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
10381780500742Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
10381780500759Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
10381780500766Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18