FDA.reportPublic FDA data

ruyue

Primary DI
06973576425215
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
06973576425215PrimaryGS10
06973576425222Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973576425215069735764252156973576425215
06973576425222069735764252226973576425222

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Sterilization Methods#

Method table
Method

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
06973576425437ruyue102024-06-07
06973576425000ruyue202024-06-07
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
06973576425437ruyueShandong 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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