FDA.reportPublic FDA data

Prism Safety Capsule System

Primary DI
00869997000109
Brand
Prism Safety Capsule System
Company
Prism Medical & Design
Model
Prism100
Catalog number
Prism100
Device description
Safety Needle Recapper
Published
2016-10-14
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
00869997000109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869997000109008699970001098699970001090869997000109

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
Total Volume30Cubic Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
754-802-1990les@prismmedicaldesign.com

Regulatory Flags#

DUNS number
085927964
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

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