FDA.reportPublic FDA data

HSW HENKE-JECT®

Primary DI
04035873059721
Brand
HSW HENKE-JECT®
Company
Henke-Sass, Wolf GmbH
Model
4850001000
Catalog number
4850001000
Device description
HSW HENKE-JECT® 2-TLG. 50 ML (60 ML)
Published
2020-12-09
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
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035873059721PackageGS110In Commercial Distribution
04035873059714PrimaryGS10
04035873059707Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035873059721040358730597214035873059721
04035873059714040358730597144035873059714
04035873059707040358730597074035873059707

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringeA sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume50Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00PROTECT FROM SUNLIGHT,KEEP DRY

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317326411
Device count
30
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 DI, Brand, Model table
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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Primary DI, Brand, Company table
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18699207302025Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207305033Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207310037Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207311003Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207320029Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207350026Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
04046955850839Omnifix®B. BRAUN MEDICAL INC.FMF2026-03-08
18800109007035DMject Insulin SyringeShinchang Medical Co., Ltd.FMF2026-03-03
18800109007073DMject Insulin SyringeShinchang Medical Co., Ltd.FMF2026-03-03
18800109007127DMject Insulin SyringeShinchang Medical Co., Ltd.FMF2026-03-03
00849296013345WelmedWELMED INC.FMF2026-02-15
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00849296013413WelmedWELMED INC.FMF2026-02-15
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00849296013437WelmedWELMED INC.FMF2026-02-15
00849296013444WelmedWELMED INC.FMF2026-02-15
00849296013451WelmedWELMED INC.FMF2026-02-15
00849296013468WelmedWELMED INC.FMF2026-02-15
00849296013475WelmedWELMED INC.FMF2026-02-15
00849296013482WelmedWELMED INC.FMF2026-02-15
00849296013499WelmedWELMED INC.FMF2026-02-15
00849296013505WelmedWELMED INC.FMF2026-02-15
20850083784007Comfort EZS.D.I. USA, INC.FMF2026-02-13