FDA.reportPublic FDA data

GD

Primary DI
10850699008484
Brand
GD
Company
Jiangsu Guangda Medical Material Group Co.,Ltd.
Model
641137-3
Catalog number
641137-3
Device description
Gauze Ball, Cylindrical, Bulk
Published
2022-12-05
Public version status
New
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
10850699008484PrimaryGS10
00850699008487Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085069900848410850699008484
00850699008487008506990084878506990084870850699008487

GMDN Terms#

Term, Definition table
TermDefinition
Dissection spongeA sterile device intended to be used for blunt tissue dissection during a surgical procedure (e.g., from gross dissection to delicate neurological surgery). It typically consists of a small sponge made of hard but absorbent material (e.g., cotton twill, gauze, rayon) and frequently including an x-ray radiopaque element; some types include a hole in the centre to facilitate manipulation with forceps. It is available in a wide range of sizes and shapes (e.g., rosebud, peanut, cherry, round, Kittner). 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
200
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
10850699008552GD511-005511-0052022-12-05
10850699008569GD511-006511-0062022-12-05
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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