FDA.reportPublic FDA data

DropSafe Sicura

Primary DI
20812383031007
Brand
DropSafe Sicura
Company
PIKDARE SPA
Model
02099940270130
Catalog number
02099940270130
Device description
PASSIVE SAFETY NEEDLE DROPSAFE SICURA G27X13 5P
Published
2023-07-16
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
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
20812383031007PackageGS140In Commercial Distribution
00812383031003PrimaryGS10
10812383030966Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081238303100720812383031007
00812383031003008123830310038123830310030812383031003
1081238303096610812383030966

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
437816603
Device count
5
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
true
Sterilization required before use
false

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
20812383031014DropSafe Sicura02099940300130020999403001302023-07-16
00812383030402PIC INSUPEN02002262000040020022620000402019-07-19
00812383030419PIC INSUPEN02022902000040020229020000402019-07-19
00812383030426PIC INSUPEN02022988000070020229880000702019-07-19
00812383030433PIC INSUPEN02022990000070020229900000702019-07-19
00812383030440PIC INSUPEN02022983000040020229830000402019-07-19

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