FDA.reportPublic FDA data

GD

Primary DI
00850699008234
Brand
GD
Company
Jiangsu Guangda Medical Material Group Co.,Ltd.
Model
UT4545
Catalog number
UT4545
Device description
Table Cover, 45x45, Non-sterile, 200pc/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
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850699008234PrimaryGS10
00850699008821Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850699008234008506990082348506990082340850699008234
00850699008821008506990088218506990088210850699008821

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918100852AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918101774AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918103037AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918141121AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918145204AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918183800InvenioGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
30193489017742MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017759MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017766MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017773MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017780MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017797MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
00380657530021ORA SYSTEM, VerifEyeAlcon Laboratories, Inc.PUI2026-07-22
00380659983313ORA SYSTEM, VerifEyeAlcon Laboratories, Inc.PUI2026-07-22
B376KB100DAB0Drape KB100 SeriesKent Imaging IncPUI2026-07-21
10198956353954CARDINAL HEALTHCardinal Health 200, LLCPUI2026-07-20
20193489029939MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
20193489029953MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
30193489028199MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
16931918102214AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918102948AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918107356AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
20193489108214MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
20888277636559MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
00628110259554MolecuLightDX Eco DarkDrapes (Case of 50)MolecuLight IncPUI2026-07-08
00628110259578MolecuLightDX DarkDrape Eco ClipMolecuLight IncPUI2026-07-08
06932523052430Equipment DrapeJiangSu MedPlus Non-Woven Manufacturer Co., LtdPUI2026-07-08
10304040193362Henry ScheinHENRY SCHEIN, INC.PUI2026-06-25
00748426263448Convertors®Microtek Medical LLCPUI2026-06-09
30680651501272HalyardO&M HALYARD, INC.PUI2026-06-08