FDA.reportPublic FDA data

Alleset

Primary DI
06931918159655
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
E16-GW2000CT
Device description
Sustainable Guidewire Basin_2500cc_Blue_with Measurements_Non-sterile_240ea/cs
Published
2023-05-17
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
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16931918159652PrimaryGS10
06931918159655Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693191815965216931918159652
06931918159655069319181596556931918159655

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+86057383617385link_dong@gri-china.com

Regulatory Flags#

DUNS number
679894738
Device count
240
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
26931918108718AllesetAGH1X5002026-03-16
06931918122109Alleset15-0500-C2026-02-13
26931918173501Invenioi80-11114G-S2026-02-13
26931918101047AllesetSM5052026-02-09
26931918108411AllesetSM4042026-02-09
26931918139798Alleset99-UPSE2436-N2026-02-09
26931918152353AllesetSM3032026-02-09
26931918161324AllesetSM1012026-02-09
26931918171170AllesetMV-0796EV-S2026-02-09
26931918172931AllesetSM2022026-02-09
26931918141807Alleset44-0796PV-VE-S12026-02-05
26931918105694InvenioGOL0602026-01-21
16931918108155Alleset41-54542026-01-21
26931918125968AllesetCS-6512026-01-21
26931918143498AllesetCS-6502026-01-21
06931918157019Alleset30-015142026-01-21
16931918174334Alleset70-501322026-01-21
26931918184279AllesetCS-6522026-01-21
06931918102354Alleset25-0005-BL-C2025-12-16
26931918171255AllesetC-2015-NS2025-12-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10889950157326Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-05-26
00888118150240PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150257PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150264PURE PECTUSKLS-Martin L.P.FSM2026-05-25
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00888118153050IXOSKLS-Martin L.P.FSM2026-05-25
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00888118153074IXOSKLS-Martin L.P.FSM2026-05-25
00888118153081IXOSKLS-Martin L.P.FSM2026-05-25
00888118154613LEVEL ONEKLS-Martin L.P.FSM2026-05-25
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