FDA.report

HSW HENKE-JECT®

Primary DI
04035873061885
Brand
HSW HENKE-JECT®
Company
Henke-Sass, Wolf GmbH
Model
4052D000V0
Catalog number
4052D000V0
Device description
HSW HENKE-JECT® 2-TLG. 5 ML (6 ML) BK 21G X 1 1/2 - 0,80 X 40 MM
Published
2020-12-08
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

Related Records

Product Codes

CodeName
FMFSyringe, Piston

Product Code Classifications

CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04035873061885PackageGS120In Commercial Distribution
04035873061878PrimaryGS10
04035873061861Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04035873061885040358730618854035873061885
04035873061878040358730618784035873061878
04035873061861040358730618614035873061861

GMDN Terms

TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Device Sizes

TypeValueUnit
Total Volume5Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00PROTECT FROM SUNLIGHT, KEEP 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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