FDA.reportPublic FDA data

GUANGYI

Primary DI
06974692680007
Brand
GUANGYI
Company
Jiangsu Guangyi Medical Dressing Co.,LTD.
Model
PU, 15cm*10m
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MHWDressing, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974692680007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974692680007069746926800076974692680007

GMDN Terms#

Term, Definition table
TermDefinition
Cast/bandage waterproof bathing cover, single-useA device made of waterproof materials designed to be placed over a treated area of the body, typically a plaster cast, stitches, bandage, dressing, or PICC line, to keep the area dry while the user is having a shower or a bath. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
526901056
Device count
1
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
06974692681561GUANGYINON-WOVEN FABRICSWITH ABSORBENT PAD10cm×10cm2026-07-22
06974692681349GUANGYINON-WOVEN FABRICS WITH ABSORBENT PAD10cm×20cm2026-04-13
06974692681356GUANGYINON-WOVEN FABRICS WITH ABSORBENT PAD10cm×30cm2026-04-13
06974692681073GUANGYIPU type 10cm×12cm2025-09-08
06974692681110GUANGYINon-woven type 10cm×10cm2025-11-05
06974692681127GUANGYINon-woven 10cm×25cm2025-11-05
16974692681070GUANGYIPU type 10cm×12cm2025-09-08

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