FDA.report

NA

Primary DI
04035873044581
Brand
NA
Company
Henke-Sass, Wolf GmbH
Model
8300026718
Catalog number
8300026718
Device description
50 ML (60 ML) SYRAMED 3-TLG LUER LOCK
Published
2016-09-12
Public version status
Update
Distribution status
Not 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
04035873044581PackageGS16Not in Commercial Distribution
04035873044598PrimaryGS10
04035873053231Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04035873044581040358730445814035873044581
04035873044598040358730445984035873044598
04035873053231040358730532314035873053231

GMDN Terms

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

TypeValueUnit
Total Volume50Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Sterilization Methods

Method

Regulatory Flags

DUNS number
317326411
Device count
50
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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