FDA.reportPublic FDA data

Alleset

Primary DI
16931918166469
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
25-S003-S
Device description
Skin Marker_Standard Tip with Ruler and Labels_sterile_100EA/CS
Published
2022-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZZMarker, Skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZZMarker, SkinGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26931918166466PackageGS1100In Commercial Distribution
16931918166469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2693191816646626931918166466
1693191816646916931918166469

GMDN Terms#

Term, Definition table
TermDefinition
Skin marking pen, single-useA dedicated pen intended to be used to delineate areas on the skin surface of a patient (e.g., to outline surgical incision sites, for dermatology applications) utilizing non-toxic ink. It is typically a felt-tip pen which may include a sterile disposable ruler. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
679894738
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16931918145563Alleseti90-4230-HB2025-11-11
16931918170893Alleset10-0282026-05-08
16931918118994Beaver Visitec Inter603004652022-12-06
16931918122182Invenioi91-61422024-02-12
16931918122380Invenioi91-4320-S12024-02-02
16931918123714Invenioi91-61302024-02-02
16931918124056Invenioi91-4330-S12024-02-02
16931918127064Invenioi90-7032-S12024-02-02
16931918128573Invenioi90-80002022-12-06
16931918129006Invenioi91-4330-HB2024-02-02
16931918129631Invenioi90-80322024-02-17
16931918134277Invenioi91-12422024-02-12
16931918137407Beaver Visitec Inter603004552022-12-05
16931918140926Invenioi90-4220-W1-HB2024-02-17
16931918140995Invenioi91-4320-HB2024-02-12
16931918142562Invenioi91-61242024-02-12
16931918142661Invenioi91-61202024-02-02
16931918143163Invenioi91-6130-W12024-02-12
16931918144641Invenioi91-1230-W1-HB2024-02-12
16931918145457Invenioi91-6130-S12024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918101040AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918108414AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918152356AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918161327AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918172934AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
10080196771844MEDLINEMEDLINE INDUSTRIES, INC.FZZ2026-01-12
40080196312710MEDLINEMEDLINE INDUSTRIES, INC.FZZ2026-01-12
40080196312741MEDLINEMEDLINE INDUSTRIES, INC.FZZ2026-01-12
10198956206045CARDINAL HEALTHCardinal Health 200, LLCFZZ2025-11-07
00661392004511LSL HEALTHCARELSL Industries, LLCFZZ2025-10-30
00661392004528LSL HEALTHCARELSL Industries, LLCFZZ2025-10-30
10080196771851MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
10884389025949MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
10884389711798MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
10884389362402MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-10
00754027700275RMAC SurgicalRMAC Surgical, IncFZZ2025-06-03
10080196326006MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-02
10198459271694Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2025-02-23
00714646001290IsoMark™Bionix, LLCFZZ2025-02-20
10884389610312Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2024-08-04
10080196031436Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2024-07-29
10197106628232CARDINAL HEALTHCardinal Health 200, LLCFZZ2024-05-07
10860010334574InkWell Health Inkwell Health LtdFZZ2023-12-14
10884389106358MedlineMEDLINE INDUSTRIES, INC.FZZ2023-12-11
20193489027218MedlineMEDLINE INDUSTRIES, INC.FZZ2023-12-11
10884389025925MedlineMEDLINE INDUSTRIES, INC.FZZ2023-10-13
00630094177267Bioseal Inc.BIOSEALFZZ2023-10-03
00630094177274Bioseal Inc.BIOSEALFZZ2023-10-03
10884389289280Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2023-10-01
10884389289310Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2023-10-01