FDA.reportPublic FDA data

N'Sure Autoclavable Pouches (5-1/4" x 11")

Primary DI
D724T8201321
Brand
N'Sure Autoclavable Pouches (5-1/4" x 11")
Company
PEARSON DENTAL SUPPLIES, INC.
Model
T820132
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

Product Codes#

Code, Name table
CodeName
FRCIndicator, Biological Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRCIndicator, Biological Sterilization ProcessGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D724T8201321PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
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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Primary DI, Brand, Model table
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D724B0105080Vivid Electrode Tip #11B8805082016-06-20
D724B8805000Vivid Surgo MaticB8805002016-06-20
D724B8805020Vivid Electrode Tip #1B8805022016-06-20
D724B8805040Vivid Electrode Tip #2B8805042016-06-20
D724B8805060Vivid Electrode Tip #6B8805062016-06-20
D724B8805100Vivid Electrode Tip #14B8801512016-06-20
D724B8805120Vivid Electrode Tip #17B8805122016-06-20
D724B8805140Vivid Electrode Tip #21B8805142016-06-20
D724B8805160Vivid Electrode Tip #31B8805162016-06-20
D724B8805180Vivid Electrode Tip #33B8805182016-06-20
D724A8605001Pearson Zirconia Blocks for Sirona InLab #5100A86-05002016-08-17
D724A8605021Pearson Zirconia Blocks for Sirona InLab #5101A86-05022016-08-17
D724A8605041Pearson Zirconia Blocks for Sirona InLab #5102A86-05042016-08-17
D724A8605061Pearson Zirconia Blocks for Sirona InLab #5103A86-05062016-08-17
D724A8605081Pearson Zirconia Blocks for Sirona InLab #5104A86-05082016-08-17
D724A8605101Pearson Zirconia Blocks for Sirona InLab #5105A86-05102016-08-17
D724N1101011Vivid TruTemp TC&BN1101012016-06-27

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Primary DI, Brand, Company table
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