FDA.report

PRACTIshield Sheath Props

Primary DI
00723896009215
Brand
PRACTIshield Sheath Props
Company
PRACTICON, INC.
Model
70-4970
Catalog number
70-4970
Device description
With new, high-visibility target graphics, PRACTIshield slips onto any needle sheath, creating an effective prop for easier one-handed resheathing. Helps to remind and reinforce a safe technique. Puncture-resistant die-cut cardboard. 100 single-use shields per pack.
Published
2018-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DZMNeedle, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00723896009215PrimaryGS10
00723896009208Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00723896009215007238960092157238960092150723896009215
00723896009208007238960092087238960092080723896009208

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
119193803
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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