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
16931918100852Alleset80-08159-HB2026-07-28
16931918101774Alleset80-08158-HB2026-07-28
16931918103037Alleset80-08157-HB2026-07-28
16931918141121AllesetMV-13313-S2026-07-28
16931918145204AllesetMV-13103-S2026-07-28
16931918180090InvenioASI0012026-07-28
16931918183800InvenioMV-13323-S2026-07-28
16931918102214AllesetCS-32092026-07-16
16931918102948AllesetCS-1100HC2026-07-16
16931918107356AllesetCS-32182026-07-16
16931918106694InvenioGOL0292026-06-25
16931918107219InvenioGOL0372026-06-25
16931918100876Alleset80-01306T2026-06-04
16931918102450Alleset001-CAM0796PS2026-06-04
16931918104201Alleset001-BND0022S2026-06-04
16931918104416Alleset001-BND3636S2026-06-04
16931918104645Alleset80-01305T2026-06-04
16931918104843Alleset001-CARM24S2026-06-04
16931918104935Alleset001-BND3020S2026-06-04
16931918105239Alleset001-BND0018S2026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196321407MEDLINEMEDLINE INDUSTRIES, INC.FYF2026-09-25
30080196293548MEDLINEMEDLINE INDUSTRIES, INC.FYF2026-09-24
20197344158895MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158918MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158932MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158956MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158970MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158987MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344159014MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344159106MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
40080196247616MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
40080196730248MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
00840118617567Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617581Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617604Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617628Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617659ENDURE INDUSTRIESENDURE INDUSTRIESOEA2026-08-03
00840118617673Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617697Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617710Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617741Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617772Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617802Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118687690Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118698399Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
30193489103964MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-28
30193489103971MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-28
30193489104893MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489107969MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489120241MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24