FDA.report

N'Sure Autoclavable Pouches (7-1/2" x 13")

Primary DI
D724T8201341
Brand
N'Sure Autoclavable Pouches (7-1/2" x 13")
Company
PEARSON DENTAL SUPPLIES, INC.
Model
T820134
Device description
PK. OF 200
Published
2016-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FRCIndicator, Biological Sterilization Process

Product Code Classifications

CodeDeviceSpecialtyClass
FRCIndicator, Biological Sterilization ProcessGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D724T8201341PrimaryHIBCC0

GMDN Terms

TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
082874108
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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