FDA.reportPublic FDA data

DropSafe Sicura

Primary DI
00812383030938
Brand
DropSafe Sicura
Company
PIKDARE SPA
Model
02094000230250
Catalog number
02094000230250
Device description
PASSIVE SAFETY NEEDLE DROPSAFE SICURA G23x25mm 50p
Published
2022-12-23
Public version status
Update
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
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223353000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223353000DropSafeTM SicuraTMPikdare Spa2022-12-02FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20812383030932PackageGS112In Commercial Distribution
00812383030938PrimaryGS10
10812383030935Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081238303093220812383030932
00812383030938008123830309388123830309380812383030938
1081238303093510812383030935

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
1-877-660-1900info@htl-strefa.com

Regulatory Flags#

DUNS number
437816603
Device count
50
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812383030853DropSafe Sicura02099940180250020999401802502023-07-16
00812383030860DropSafe Sicura02099940210250020999402102502023-07-16
00812383030877DropSafe Sicura02099940220250020999402202502023-07-16
00812383030884DropSafe Sicura02099940230250020999402302502023-07-16
00812383030983DropSafe Sicura02099940250250020999402502502023-07-16
00812383030990DropSafe Sicura02099940250160020999402501602023-07-16
00812383031003DropSafe Sicura02099940270130020999402701302023-07-16
00812383031010DropSafe Sicura02099940300130020999403001302023-07-16
20812383030857DropSafe Sicura02099940180250020999401802502023-07-16
20812383030864DropSafe Sicura02099940210250020999402102502023-07-16
20812383030871DropSafe Sicura02099940220250020999402202502023-07-16
20812383030888DropSafe Sicura02099940230250020999402302502023-07-16
20812383030987DropSafe Sicura02099940250250020999402502502023-07-16
20812383030994DropSafe Sicura02099940250160020999402501602023-07-16
20812383031007DropSafe Sicura02099940270130020999402701302023-07-16
20812383031014DropSafe Sicura02099940300130020999403001302023-07-16
00812383030402PIC INSUPEN02002262000040020022620000402019-07-19
00812383030419PIC INSUPEN02022902000040020229020000402019-07-19
00812383030426PIC INSUPEN02022988000070020229880000702019-07-19
00812383030433PIC INSUPEN02022990000070020229900000702019-07-19

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