FDA.reportPublic FDA data

Orabloc - needle stick safety system

Primary DI
08051040583000
Brand
Orabloc - needle stick safety system
Company
PIERREL SPA
Model
20200707
Catalog number
20200707
Device description
The Needlestick Safety system is designed for safely recapping needles. The device consists of a disk, filled with 100 micro rubber caps, suitable for recapping needles after utilisation, for a safe disposal.
Published
2020-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08051040583000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051040583000080510405830008051040583000

GMDN Terms#

Term, Definition table
TermDefinition
Needle recapping device, single-useA device intended to hold a needle cap and allow a user to conveniently recap a needle, providing some user protection against needle sticks. This is a single-use device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place at +5°C(41°F) to +40°C(104°F)

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390823626111f.velotti@pierrelgroup.com

Regulatory Flags#

DUNS number
458463044
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08051040582003G.o.c.c.l.e.s.G.o.c.c.l.e.s.5310006012016-10-21
08051040582010G.o.c.c.l.e.s. lightG.o.c.c.l.e.s. light5310006112016-10-21

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08056999020385SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
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