FDA.reportPublic FDA data

GD

Primary DI
10850699008453
Brand
GD
Company
Jiangsu Guangda Medical Material Group Co.,Ltd.
Model
362204-10
Catalog number
362204-10
Device description
SPONGE, Non-woven, 4PLY, 2X2, banded in 10's, 8000pc/case
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
10850699008453PrimaryGS10
00850699008456Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085069900845310850699008453
00850699008456008506990084568506990084560850699008456

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum; in some cases, the device’s packaging may be used as a disposable tray. 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
8000
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
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
10850699008552GD511-005511-0052022-12-05
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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