FDA.reportPublic FDA data

PATIENT PACK NSU V2

Primary DI
M75257029021
Brand
PATIENT PACK NSU V2
Company
STRADIS MEDICAL LLC
Model
570-2902
Device description
HENRY SCHEIN DENTAL TRAINING FOR DENTAL SURGURY. THIS PACK CONTAINS PATIENT PPE USED IN SUPPORT OF ORAL SURGERY. HENRY SCHEIN PRODUCT FOR NSU.
Published
2022-05-03
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
PWLOral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWLOral Surgery TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M75257029025PackageHIBCC30In Commercial Distribution
M75257029021PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-424-8520cs@stradishealthcare.com

Regulatory Flags#

DUNS number
043537671
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M752HCT8249CP3A5Stradis Medical, LLC.HCT8249CP-3A2020-11-03
M752HCT900CHX0ARTERIAL LINE DRESSING CHANGE KITHCT900CHX2022-01-10
M752TMCLK15Stradis Medical, LLCTMCLK-12019-12-23
M7525113885Stradis Medical, LLC.5113882020-03-25
M752BRF060MSP201DC5Stradis Medical, LLC.BRF-060MSP201DC2019-08-01
M752CD22005Stradis Medical, LLCCD-22002019-08-29
M752DC5485Stradis Medical, LLC.DC-5482019-12-20
M752DC8903CP25Stradis Medical, LLCDC8903CP-22021-09-01
M752IM12675Stradis Medical, LLC.IM12672020-06-12
M752MSDCC183000DRESSING CHANGE TRAYMSDC-C183002022-05-16
M752HCT5975OKB0Stradis Medical, LLC.HCT5975OK-B2021-04-09
M752HCT7478PIV2A5Stradis Medical, LLC.HCT7478PIV2A2021-04-21
M752HCT8428CP25Stradis Medical, LLC.HCT8428CP-22020-11-23
M752HCT984915Stradis Medical, LLC.HCT9849-12020-06-08
M57257028311IV START KIT570-28312022-03-28
M752HCT200GDBP5Stradis Medical, LLCHCT200GD-BP2021-10-06
M752RWM69KTA015Stradis Medical, LLCRWM-69K-TA012021-09-30
M752WC2505Stradis Medical, LLC.WC-2502021-08-23
M752HCT354822Stradis Medical, LLCHCT3548-22021-08-13
M752ZZ09585Stradis Medical, LLCZZ-09582021-07-27

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