FDA.report

NA

Primary DI
G2805758000
Brand
NA
Company
Nsi US
Model
575-800
Catalog number
575-800
Device description
Clear-Line M-Black Sterilization CASE for NSI-8001
Published
2022-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LRPTray, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G2805758000PrimaryHIBCC0

GMDN Terms

TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
303-860-0261info@nsi-healthsystems.com

Regulatory Flags

DUNS number
100367091
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
true

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G280NSI1670R0NANSI-1670RNSI-1670R2022-07-12
G280NSI1680R0NANSI-1680RNSI-1680R2022-07-12
G280NSI1690R0NANSI-1690RNSI-1690R2022-07-12
G280NSI1830R0NANSI-1830RNSI-1830R2022-07-12
G280NSI1840R0NANSI-1840RNSI-1840R2022-07-12
G280NSI1850R0NANSI-1850RNSI-1850R2022-07-12
G280NSI1860R0NANSI-1860RNSI-1860R2022-07-12
G280NSI1870R0NANSI-1870RNSI-1870R2022-07-12
G280NSI1880R0NANSI-1880RNSI-1880R2022-07-12

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