FDA.reportPublic FDA data

DropSafe® Insulin Safety Syringe with Fixed Needle

Primary DI
05903999600785
Brand
DropSafe® Insulin Safety Syringe with Fixed Needle
Company
HTL STREFA S A
Model
0.3ml 31G x 6mm
Catalog number
6082
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
OTC
false
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
05903999600785PackageGS1100In Commercial Distribution
25903999600789PackageGS18In Commercial Distribution
85903999600781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05903999600785059039996007855903999600785
2590399960078925903999600789
8590399960078185903999600781

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
422528088
Device count
1
DM exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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05903999601775DropSafe, safety pen needles31G x 6mm84322022-09-28
05903999601782DropSafe, safety pen needles31G x 8mm84332022-09-28
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00857273002992droplet® pen needles32G x 6mm 75202026-04-21
05907996093045droplet® pen needles29G x 12mm83082016-09-22
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05907996093038droplet® pen needles29G x 10mm83072016-09-22
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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
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