FDA.reportPublic FDA data

Alleset

Primary DI
06931918182738
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
Model 60-1010
Device description
Bouffant Cap_ White_21"_300/cs
Published
2021-02-27
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
FYFCAP, SURGICAL
OEANon-Surgical Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYFCap, SurgicalGeneral, Plastic Surgery1
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16931918182735PrimaryGS10
06931918182738Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693191818273516931918182735
06931918182738069319181827386931918182738

GMDN Terms#

Term, Definition table
TermDefinition
Surgical cap, single-useA non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
679894738
Device count
300
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
false

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
10097604577028Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10197106720950CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106720974CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721032CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721056CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106472408CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10097604466407Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2024-09-16
10097604414033Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604419014Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604455029Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604474112Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10193489099560MEDLINEMEDLINE INDUSTRIES, INC.OEA2024-07-04
10197106675250CARDINAL HEALTHCardinal Health 200, LLCOEA2024-06-27
10197106665183CARDINAL HEALTHCardinal Health 200, LLCOEA2024-06-25
10197106688199CARDINAL HEALTHCardinal Health 200, LLCOEA2024-06-18
10197106650493CARDINAL HEALTHCardinal Health 200, LLCOEA2024-06-10
10197106652565CARDINAL HEALTHCardinal Health 200, LLCOEA2024-06-07
10197106648605CARDINAL HEALTHCardinal Health 200, LLCOEA2024-05-20
10197106621349CARDINAL HEALTHCardinal Health 200, LLCOEA2024-05-16
10197106636480CARDINAL HEALTHCardinal Health 200, LLCOEA2024-05-16
10197106645918CARDINAL HEALTHCardinal Health 200, LLCOEA2024-05-07
10197106646625CARDINAL HEALTHCardinal Health 200, LLCOEA2024-05-02
10197106653296CARDINAL HEALTHCardinal Health 200, LLCOEA2024-04-29
10197106627259CARDINAL HEALTHCardinal Health 200, LLCOEA2024-04-17
10197106589380CARDINAL HEALTHCardinal Health 200, LLCOEA2024-04-08
10197106592151CARDINAL HEALTHCardinal Health 200, LLCOEA2024-04-08
10197106613801CARDINAL HEALTHCardinal Health 200, LLCOEA2024-03-26
10197106489062CARDINAL HEALTHCardinal Health 200, LLCOEA2024-03-20
10197106558959CARDINAL HEALTHCardinal Health 200, LLCOEA2024-03-11