FDA.report

Alleset

Primary DI
06931918177932
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
Ei15-GW2000CT
Device description
Sustainable Bowl Guidwire 2500ml _Blue_160ea/cs
Published
2023-05-22
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

Related Records

Contact Domains

Product Codes

CodeName
FSMTray, Surgical, Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16931918177939PrimaryGS10
06931918177932Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1693191817793916931918177939
06931918177932069319181779326931918177932

GMDN Terms

TermDefinition
General-purpose bowl, single-useA portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This disposable device will typically be incinerated along with its contents if used for waste. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+86057383617385link_dong@gri-china.com

Regulatory Flags

DUNS number
679894738
Device count
160
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
true
Sterilization required before use
false

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26931918125968AllesetCS-6512026-01-21
26931918143498AllesetCS-6502026-01-21
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16931918174334Alleset70-501322026-01-21
26931918184279AllesetCS-6522026-01-21
06931918102354Alleset25-0005-BL-C2025-12-16
26931918171255AllesetC-2015-NS2025-12-09

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