FDA.reportPublic FDA data

Alleset

Primary DI
06931918132405
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
Model 60-1060
Device description
Beard Cover_Universal_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
OEANon-Surgical Gown
PUIDrape, surgical, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16931918132402PrimaryGS10
06931918132405Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693191813240216931918132402
06931918132405069319181324056931918132405

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-use, non-sterileA non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device intended to be sterilized prior to use.

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
08681756013401PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIPUI2025-12-26
08682952400545PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIPUI2025-12-26
10097604577028Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10080196073306MEDLINEMEDLINE INDUSTRIES, INC.PUI2025-06-19
10097604466407Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2024-09-16
10097604546727Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2023-12-11
10097604546741Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2023-12-11
10080196073351MedlineMEDLINE INDUSTRIES, INC.PUI2023-10-24
10080196739240MedlineMEDLINE INDUSTRIES, INC.PUI2023-10-12
08052141310069Green gown with elastics (length 120 cm)OMNIA SRLOEA2023-06-22
08052141310083Green gown with cuffs (length 120 cm)OMNIA SRLOEA2023-06-22
08052141310120Expo model gown (length 130 cm) size M/LOMNIA SRLOEA2023-06-22
08052141310144Expo model gown (length 133 cm) size XLOMNIA SRLOEA2023-06-22
08052141310182Expo model gown (length 118 cm) size SOMNIA SRLOEA2023-06-22
08052141310267Light blue gown with cuffs (length 120 cm)OMNIA SRLOEA2023-06-22
08052141310281Yellow gown with elastics (length 120 cm)OMNIA SRLOEA2023-06-22
08052141310304Yellow gown with cuffs (length 120 cm)OMNIA SRLOEA2023-06-22
08052141310328Light blue gown with elastics (length 120 cm)OMNIA SRLOEA2023-06-22
08052141310342Special Plus model gown (length 112 cm) size SOMNIA SRLOEA2023-06-22
08052141310366Special Plus model gown (length 112 cm) size MOMNIA SRLOEA2023-06-22
08052141310380Special Plus model gown (length 112 cm) size LOMNIA SRLOEA2023-06-22
08052141310403Special Plus model gown (length 118 cm) size XLOMNIA SRLOEA2023-06-22
08052141310427Special Plus model gown (length 130 cm) size XXLOMNIA SRLOEA2023-06-22
08056646507139Green gown with elastics (length 120 cm)OMNIA SRLOEA2023-06-22
08056646507153Green gown with cuffs (length 120 cm)OMNIA SRLOEA2023-06-22
08056646507191Expo model gown (length 130 cm) size M/LOMNIA SRLOEA2023-06-22
08056646507214Expo model gown (length 133 cm) size XLOMNIA SRLOEA2023-06-22
08056646507238Expo model gown (length 135 cm) size XXLOMNIA SRLOEA2023-06-22
08056646507276Light blue gown with cuffs (length 120 cm)OMNIA SRLOEA2023-06-22