FDA.reportPublic FDA data

Needle Guide

Primary DI
00815212022807
Brand
Needle Guide
Company
Izi Medical Products, LLC
Model
NG4010-2
Published
2017-02-02
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

Product Codes#

Code, Name table
CodeName
GDFGuide, Needle, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815212022807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815212022807008152120228078152120228070815212022807

GMDN Terms#

Term, Definition table
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 table
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 DI, Brand, Model table
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

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