FDA.report

Droplet, Lancing Device

Primary DI
05907996090327
Brand
Droplet, Lancing Device
Company
HTL STREFA S A
Model
n/a
Catalog number
9006
Device description
he Droplet Lncing Device is a convenient medical device for use with exchangeable lancets in order to collect capillary blood samples for glucose monitoring or other tests.
Published
2019-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FMKLancet, Blood

Product Code Classifications

CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15907996090324PackageGS140In Commercial Distribution
05907996090327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1590799609032415907996090324
05907996090327059079960903275907996090327

GMDN Terms

TermDefinition
Manual blood lancing device, reusableA hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+484227000010info@htl-strefa.com

Regulatory Flags

DUNS number
422528088
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
true
Sterilization required before use
false

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