FDA.reportPublic FDA data

V-Guide

Primary DI
08800142924088
Brand
V-Guide
Company
RF Medical Co.,Ltd.
Model
VG1602S
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
08800142924088PackageGS110In Commercial Distribution
08800142924095PackageGS120In Commercial Distribution
08800142924071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800142924088088001429240888800142924088
08800142924095088001429240958800142924095
08800142924071088001429240718800142924071

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
00198506093692ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506093708ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506093715ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506093722ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506092466ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092473ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092480ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092497ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092503ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092510ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092527ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092534ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092541ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092558ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092565ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092572ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00348783011265Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
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00348783011296Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011302Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011319Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
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