FDA.report

Needle Guide

Primary DI
00815212022029
Brand
Needle Guide
Company
Izi Medical Products, LLC
Model
S-NG4010-1
Published
2017-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GDFGuide, Needle, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815212022029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815212022029008152120220298152120220290815212022029

GMDN Terms

TermDefinition
Cervical anaesthesia kitA collection of sterile devices designed to deliver an analgesic or anaesthetic agent to function as an intracervical nerve-block and/or a paracervical regional nerve-block (sometimes including uterosacral and pudendal regions). It is typically used for gyneacological diagnostic tests such as dilation and curettage, small excisional procedures such as endometrial biopsy, or for pain management during labour and/or delivery. It typically consists of a procedural needle, syringe, catheter, and a filter. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
933506164
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
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 DIBrandModelCatalogPublished
00815212026973BLAZER-C CURVED INJECTION SYSTEM-MVBZK31602025-05-21
00815212026966OS 11G BONE FILLER KIT-OSTEOFIXG800122025-03-26
00815212026942BKP-10-12.0-15.0-BG10015B2025-01-08
00815212026959BKP-11-12.0-15.0-BG11015B2025-01-08
00815212026935Duro-Ject Bone Cement Injection TubeG135502024-10-14
00815212026911KIT:BALLOON AND BONE FILLERVBBF0012024-08-28
00815212026928KIT:BALLOON,FILLER,ACCESS,DRILLVBBF0022024-08-28
10815212026895OsteoPearl Vertebral Balloon (15mm), 10G100.4122024-08-05
00815212026904OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G100.4102024-08-05
00815212024467STRYKER NAVIGATED BIOPSY NEEDLE6000-805-8002024-07-30
00815212026874BKP-10-12.0-15.0-AG10015A2024-06-28
00815212026881BKP-11-12.0-15.0-AG11015A2024-06-28
00815212026867MDT NAVIGATED BIOPSY, COMPATIABLE 7DMB3000-7D-I2024-03-18
00815212026812ONPOINT NAVIGATION KITDK02101012024-02-27
00815212026829ONPOINT NAVIGATION TRAYDP02101012024-02-27
00815212026836ONPOINT SNAP SPHERZ 25PKDS02125012024-02-27
00815212026843ONPOINT SPHERZ PASSIVE MARKER-12 PACKDS02112012024-02-27
00815212026850ONPOINT PEDICLE ACCESS NEEDLEDJ02101012024-02-27
10815212026819ONPOINT NAVIGATION 10 BOXDK02110012024-02-27
20815212026816ONPOINT NAVIGATION 25 BOXESDK02125012024-02-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
03662663161220PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCGDF2026-02-16
03662663161237PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCGDF2026-02-16
03662663161961Vital MIS Spinal Fixation SystemHighridge Medical, LLCGDF2026-02-16
00850031983014OCCIGUIDEVAULT PARAGON GROUP, INC.GDF2026-01-07
03662663244442Vital MIS Spinal Fixation SystemHighridge Medical, LLCGDF2025-12-18
03662663244466Vital MIS Spinal Fixation SystemHighridge Medical, LLCGDF2025-12-18
03662663276412Timberline Lateral Fusion SystemHighridge Medical, LLCGDF2025-12-18
03662663276429Timberline Lateral Fusion SystemHighridge Medical, LLCGDF2025-12-18
03662663276788Timberline Lateral Fusion SystemHighridge Medical, LLCGDF2025-11-17
03662663135924Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCGDF2025-11-14
20197344044792MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
20197344044808MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
00194613059095MSI Precision Specialty InstrumentsMed Saver, Inc.GDF2025-08-01
10850012846434PicoDriverLSI Solutions, Inc.GDF2025-07-19
05010058179820InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058182639InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058182646InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058183643InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058182622InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-18
05010058178953InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-05-21
05010058179943InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-05-21
04049047675808GimmiGimmi GmbHGDF2025-05-06
04049047675815GimmiGimmi GmbHGDF2025-05-06
04049047675884GimmiGimmi GmbHGDF2025-05-06
04049047675891GimmiGimmi GmbHGDF2025-05-06
04049047675907GimmiGimmi GmbHGDF2025-05-06
04049047675945GimmiGimmi GmbHGDF2025-05-06
04049047675952GimmiGimmi GmbHGDF2025-05-06
04049047675969GimmiGimmi GmbHGDF2025-05-06
04049047675976GimmiGimmi GmbHGDF2025-05-06