FDA.report

HSW FINE-JECT®

Primary DI
04035873021384
Brand
HSW FINE-JECT®
Company
Henke-Sass, Wolf GmbH
Model
4710011025
Catalog number
4710011025
Device description
HSW FINE-JECT® 1,10X25 MM / 19GX1" STERILE
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications

CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04035873021384PackageGS130In Commercial Distribution
04035873021391PrimaryGS10
04035873052425Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04035873021384040358730213844035873021384
04035873021391040358730213914035873021391
04035873052425040358730524254035873052425

GMDN Terms

TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes

TypeValueUnit
Outer Diameter1.1Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Sterilization Methods

Method

Regulatory Flags

DUNS number
317326411
Device count
100
DM exempt
true
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04035873013006HSW LIGMAJECT® I210100010021010001002017-11-06
04035873013020HSW LIGMAJECT® II210200010021020001002017-11-06
04035873027195HSW HENKE-JECT®211800007721180000772018-02-23
04035873033646HSW Cartridge Syringe CW293071810129307181012017-11-06
04035873035817HSW SOFT-JECT® 21030001002018-11-05
04035873035831HSW SOFT-JECT® 83000051972018-11-05
04035873056799HENKE-DENT 3000 SA830001588483000158842018-01-24
04035873057093HENKE-DENT 500 SOFT-GRIP830004238183000423812017-12-22
04035873057109HENKE-DENT 500 SOFT-GRIP830004238283000423822017-12-22
04035873057116HENKE-DENT 500 SOFT-GRIP830004238383000423832017-12-22
04035873057123HENKE-DENT 500 SOFT-GRIP830004238483000423842017-12-22
04035873057130HENKE-DENT 500 SOFT-GRIP830004238583000423852017-12-22
04035873057147HENKE-DENT 500 SOFT-GRIP 830004238683000423862017-12-22
04035873057154HENKE-DENT 500 SOFT-GRIP830004238783000423872017-12-22
04035873057161HENKE-DENT 500 SOFT-GRIP 830004238883000423882017-12-22
04035873055549NA830003857183000385712017-08-04
04035873055556NA830003857283000385722017-08-04
04035873055563NA830003857383000385732017-08-04
04035873055570NA830003857483000385742017-08-04
04035873055587NA830003857583000385752017-08-04

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