FDA.reportPublic FDA data

GD

Primary DI
10850699008552
Brand
GD
Company
Jiangsu Guangda Medical Material Group Co.,Ltd.
Model
511-005
Catalog number
511-005
Device description
Non-sterile Fluftex Gauze Roll, 600Cs
Published
2022-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850699008552PrimaryGS10
00850699008555Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085069900855210850699008552
00850699008555008506990085558506990085550850699008555

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze roll/sheetA device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature32 Degrees Fahrenheit100 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
630.842.6595operations@gdmed.com

Regulatory Flags#

DUNS number
421295761
Device count
600
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850699008446GD363304-10363304-102022-12-05
10850699008453GD362204-10362204-102022-12-05
20850699008498GD4-4130-G4-4130-G2022-12-05
00850699008098GD364404-10364404-102022-12-05
10850699008170GDUT5454UT54542022-12-05
00850699008210GDUT5472UT54722022-12-05
00850699008234GDUT4545UT45452022-12-05
00850699008470GDUT2727UT27272022-12-05
10850699008514GD7-96037-96032022-12-05
00850699008197GDBB3040BB30402022-12-05
10850699008569GD511-006511-0062022-12-05
10850699008484GD641137-3641137-32022-12-05
10850699008545GD231818PWNL231818PWNL2022-12-05
10850699008606GD221818PWR221818PWR2022-12-05
10850699008620GD291212PW-X291212PW-X2022-12-05
00850699008111GD7-96007-96002022-12-05
00850699008685GD291818PW-X291818PW-X2022-12-05
00850699008852GD364404-10364404-102022-12-05
00850699008227GD7-96007-96002022-12-05
00850699008845GDBB3040BB30402022-12-05

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