FDA.reportPublic FDA data

DropSafe® Insulin Safety Syringe with Fixed Needle

Primary DI
85903999600712
Brand
DropSafe® Insulin Safety Syringe with Fixed Needle
Company
HTL STREFA S A
Model
0.5ml 31G x 8mm
Catalog number
6078
Device description
DropSafe® Insulin Safety Syringe with Fixed Needle is hypodermic syringe with an attached safety shield to cover the needle. This device is intended for the delivery of U-100 insulin.
Published
2021-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132681000SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGESol-Millennium Medical, Inc.2014-05-22MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05903999600716PackageGS1100In Commercial Distribution
25903999600710PackageGS18In Commercial Distribution
85903999600712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05903999600716059039996007165903999600716
2590399960071025903999600710
8590399960071285903999600712

Contacts#

Phone, Email table
PhoneEmail
+48422700010info@htl-strefa.com

Regulatory Flags#

DUNS number
422528088
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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05903999601775DropSafe, safety pen needles31G x 6mm84322022-09-28
05903999601782DropSafe, safety pen needles31G x 8mm84332022-09-28
05903999601799DropSafe, safety pen needles31G x 5mm87972022-09-28
00857273002992droplet® pen needles32G x 6mm 75202026-04-21
05907996093045droplet® pen needles29G x 12mm83082016-09-22
05907996093069droplet® pen needles31G x 5mm83102016-09-22
05907996093038droplet® pen needles29G x 10mm83072016-09-22
05907996093052droplet® pen needles31G x 8mm83092016-09-22
00857273002473Clickfine® pen needles31G x 5 mm78092026-02-17
00857273002480Clickfine® pen needles31G x 6 mm97492026-02-17
00857273002541Clickfine® pen needles31G x 8 mm97282026-02-17
00857273002558Clickfine® pen needles32G x 4 mm97512026-02-17
10857273002470Clickfine® pen needles31G x 5 mm78092026-02-17
10857273002487Clickfine® pen needles31G x 6 mm97492026-02-17
10857273002548Clickfine® pen needles31G x 8 mm97282026-02-17
10857273002555Clickfine® pen needles32G x 4 mm97512026-02-17
05907996090327Droplet, Lancing Devicen/a90062019-11-01
05901549097535droplet ® personal lancet33G72062019-12-01
05901549097542droplet ® personal lancet33G72072019-12-01

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