FDA.report

Stradis

Primary DI
M75257030920
Brand
Stradis
Company
STRADIS MEDICAL, LLC
Model
570-3092
Device description
Bone Marrow Tray - DPT 570-3092 Bone Marrow Kit
Published
2022-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
PXOBone Marrow Biopsy Tray

Product Code Classifications

CodeDeviceSpecialtyClass
PXOBone Marrow Biopsy TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M75257030920PrimaryHIBCC0

GMDN Terms

TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
770-962-2425service@stradishealthcare.com

Regulatory Flags

DUNS number
174262477
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

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M7529992814755Stradis Medical, LLC.9992814752018-12-17
M7529992814765Stradis Medical, LLC.9992814762018-09-27
M7529992815585Stradis Medical, LLC.9992815582018-12-13
M752682PREG1Stradis Medical, LLC682-PREG2017-08-08
M75257032000STRADIS HEALTHCARE570-32002022-12-19
M75257032180STRADIS HEALTHCARE570-32182022-12-19
M75257032310STRADIS HEALTHCARE570-32312022-12-19
M75257032380STRADIS HEALTHCARE570-32382022-12-20
M7521000125Stradis Medical, LLC.1000122018-10-08
M7521000161Stradis Medical, LLC.1000162018-10-08
M7521000175Stradis Medical, LLC1000172018-10-08

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