FDA.reportPublic FDA data

ruyue

Primary DI
06973576425437
Brand
ruyue
Company
Shandong Ruyue Medical Technology Co.,Ltd
Model
10
Published
2024-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FMCPatient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMCPatient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973576425437PrimaryGS10
06973576425444Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973576425437069735764254376973576425437
06973576425444069735764254446973576425444

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with talcum powder and it does not have antimicrobial features. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Regulatory Flags#

DUNS number
554529787
Device count
1000
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973576425543ruyue122024-06-11
06973576425550ruyue122024-06-11
06973576425321ruyue102024-06-07
06973576425000ruyue202024-06-07
06973576425215ruyue102024-06-07
06973576425338ruyue102024-06-07
06973576425444ruyue102024-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973576425321ruyueShandong Ruyue Medical Technology Co.,LtdFMC2024-06-07
06973576425215ruyueShandong Ruyue Medical Technology Co.,LtdFMC2024-06-07
06973576425338ruyueShandong Ruyue Medical Technology Co.,LtdFMC2024-06-07
06973576425444ruyueShandong Ruyue Medical Technology Co.,LtdFMC2024-06-07
00850056091152CORRECT TOUCHCt InternationalFMC2024-01-15
00850056091169CORRECT TOUCHCt InternationalFMC2024-01-15
00850056091176CORRECT TOUCHCt InternationalFMC2024-01-15
00850056091183CORRECT TOUCHCt InternationalFMC2024-01-15
00850056091190CORRECT TOUCHCt InternationalFMC2024-01-15
00850056091206CORRECT TOUCHCt InternationalFMC2024-01-15
00850056091213CORRECT TOUCHCt InternationalFMC2024-01-15
00850056091220CORRECT TOUCHCt InternationalFMC2024-01-15
00850057303087CORRECT TOUCHCt InternationalFMC2024-01-15
00850057303094CORRECT TOUCHCt InternationalFMC2024-01-15
00850057303100CORRECT TOUCHCt InternationalFMC2024-01-15
00850057303117CORRECT TOUCHCt InternationalFMC2024-01-15
00850057303124CORRECT TOUCHCt InternationalFMC2024-01-15
00850057303131CORRECT TOUCHCt InternationalFMC2024-01-15
00850057303148CORRECT TOUCHCt InternationalFMC2024-01-15
00850057303155CORRECT TOUCHCt InternationalFMC2024-01-15
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