FDA.reportPublic FDA data

GD

Primary DI
00850699008463
Brand
GD
Company
Jiangsu Guangda Medical Material Group Co.,Ltd.
Model
101830B
Catalog number
101830B
Device description
O.R. Blue Towels, 18x30 Bulk Non-sterile
Published
2022-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10850699008460PrimaryGS10
00850699008463Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085069900846010850699008460
00850699008463008506990084638506990084630850699008463

GMDN Terms#

Term, Definition table
TermDefinition
Surgical towelA sterile cloth used in the operating room (OR) to absorb extraneous fluids. 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
400
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426121861OLYMPUSMicrotek Medical LLCPUI2026-05-28
07466532979338Moon SurgicalDAS Medical International SRLPUI2026-05-28
08681756013401PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIPUI2025-12-26
08682952400545PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIPUI2025-12-26
10192253066586CONVERTORSCardinal Health 200, LLCPUI2025-11-07
10192253066531CONVERTORSCardinal Health 200, LLCPUI2025-09-24
10080196073306MEDLINEMEDLINE INDUSTRIES, INC.PUI2025-06-19
10192253066494CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066500CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066517CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066524CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066548CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066555CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066562CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066579CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066593CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066609CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066616CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066623CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066654CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066692CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066708CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253050233CONVERTORSCardinal Health 200, LLCPUI2024-09-10
10192253050240CONVERTORSCardinal Health 200, LLCPUI2024-09-10
10080196073351MedlineMEDLINE INDUSTRIES, INC.PUI2023-10-24
10080196739240MedlineMEDLINE INDUSTRIES, INC.PUI2023-10-12
10080196313846MedlineMEDLINE INDUSTRIES, INC.PUI2023-06-08
10080196744626MedlineMEDLINE INDUSTRIES, INC.PUI2023-06-08
10080196283248MedlineMEDLINE INDUSTRIES, INC.PUI2023-01-06
10080196746842MedlineMEDLINE INDUSTRIES, INC.PUI2023-01-06