FDA.reportPublic FDA data

Cureguard

Primary DI
06938275200365
Brand
Cureguard
Company
Jiangsu Cureguard Glove Co., Ltd.
Model
XS
Published
2021-05-25
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
LZYProsthesis, Hip, Hemi-, Femoral, Metal Ball

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZYProsthesis, Hip, Hemi-, Femoral, Metal BallOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06938275200365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06938275200365069382752003656938275200365

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527942388
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938275200686CureguardXS2026-03-30
06938275200693CureguardS2026-03-30
06938275200723CureguardXL2026-03-30
06938275200730CureguardM2026-03-30
06938275200747CureguardL2026-03-30
06938275200754CureguardXS2026-03-30
06938275200761CureguardS2026-03-30
06938275200778CureguardL2026-03-30
06938275200785CureguardXL2026-03-30
06938275200792CureguardM2026-03-30
06938275200815CureguardXS2026-03-30
06938275200822CureguardS2026-03-30
06938275200839CureguardM2026-03-30
06938275200846CureguardL2026-03-30
06938275200853CureguardXL2026-03-30
06938275200372CureguardS2021-05-26
06938275200389CureguardM2021-05-26
06938275200396CureguardL2021-05-26
06938275200402CureguardXL2021-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630030804342AMIStem-H Proximal CoatingMedacta International SALZY2021-10-22
07630030804359AMIStem-H Proximal CoatingMedacta International SALZY2021-10-22
07630030804458AMIStem-H Proximal CoatingMedacta International SALZY2021-10-22
07630040719988AMIStem-PMedacta International SALZY2021-10-22
07630040719995AMIStem-PMedacta International SALZY2021-10-22
07630040720007AMIStem-PMedacta International SALZY2021-10-22
07630040720014AMIStem-PMedacta International SALZY2021-10-22
07630040720021AMIStem-PMedacta International SALZY2021-10-22
07630040720038AMIStem-PMedacta International SALZY2021-10-22
07630040720045AMIStem-PMedacta International SALZY2021-10-22
07630040720052AMIStem-PMedacta International SALZY2021-10-22
07630040720069AMIStem-PMedacta International SALZY2021-10-22
07630040720076AMIStem-PMedacta International SALZY2021-10-22
07630040720083AMIStem-PMedacta International SALZY2021-10-22
07630040720090AMIStem-PMedacta International SALZY2021-10-22
07630040720106AMIStem-PMedacta International SALZY2021-10-22
07630040720113AMIStem-PMedacta International SALZY2021-10-22
07630040720120AMIStem-PMedacta International SALZY2021-10-22
07630040720137AMIStem-PMedacta International SALZY2021-10-22
07630040720144AMIStem-PMedacta International SALZY2021-10-22
07630040720151AMIStem-PMedacta International SALZY2021-10-22
07630040720168AMIStem-PMedacta International SALZY2021-10-22
07630040720175AMIStem-PMedacta International SALZY2021-10-22
07630040720182AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720199AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720205AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720212AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720229AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720236AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720243AMIStem-P CollaredMedacta International SALZY2021-10-22