GD 211836PWNB

GUDID 00850699008647

Lap Sponges, 18x36, 360pc/case Bulk Non-sterile

Jiangsu Guangda Medical Material Group Co.,Ltd.

Radiopaque woven surgical sponge
Primary Device ID00850699008647
NIH Device Record Key94833566-987b-42d2-9d4b-cf1e3789ff12
Commercial Distribution StatusIn Commercial Distribution
Brand NameGD
Version Model Number211836PWNB
Catalog Number211836PWNB
Company DUNS421295761
Company NameJiangsu Guangda Medical Material Group Co.,Ltd.
Device Count360
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone630.842.6595
Emailoperations@gdmed.com
Phone630.842.6595
Emailoperations@gdmed.com
Phone630.842.6595
Emailoperations@gdmed.com
Phone630.842.6595
Emailoperations@gdmed.com
Phone630.842.6595
Emailoperations@gdmed.com
Phone630.842.6595
Emailoperations@gdmed.com
Phone630.842.6595
Emailoperations@gdmed.com
Phone630.842.6595
Emailoperations@gdmed.com
Phone630.842.6595
Emailoperations@gdmed.com
Phone630.842.6595
Emailoperations@gdmed.com
Phone630.842.6595
Emailoperations@gdmed.com
Phone630.842.6595
Emailoperations@gdmed.com
Phone630.842.6595
Emailoperations@gdmed.com
Phone630.842.6595
Emailoperations@gdmed.com
Phone630.842.6595
Emailoperations@gdmed.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850699008647 [Unit of Use]
GS110850699008644 [Primary]

FDA Product Code

GDYGauze/Sponge, Internal, X-Ray Detectable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850699008647]

Ethylene Oxide

[00850699008647]

Ethylene Oxide

[00850699008647]

Ethylene Oxide

[00850699008647]

Ethylene Oxide

[00850699008647]

Ethylene Oxide

[00850699008647]

Ethylene Oxide

[00850699008647]

Ethylene Oxide

[00850699008647]

Ethylene Oxide

[00850699008647]

Ethylene Oxide

[00850699008647]

Ethylene Oxide

[00850699008647]

Ethylene Oxide

[00850699008647]

Ethylene Oxide

[00850699008647]

Ethylene Oxide

[00850699008647]

Ethylene Oxide

[00850699008647]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-12
Device Publish Date2022-12-04

On-Brand Devices [GD]

00850699008623Lap Sponges, 12x12, 1400pc/case Bulk Non-sterile
00850699008760O.R. Blue Towel Xray Bulk Non-sterile
00850699008661O.R. Towel White 1.5" Fenestration Bulk Non-sterile
00850699008647Lap Sponges, 18x36, 360pc/case Bulk Non-sterile
00850699008630O.R. Towel Blue 13"x 17" 1.5" Fenestration Bulk Non-sterile
00850699008531Lap Sponges, 18x18, unwashed 800pc/case Bulk Non-sterile
00850699008463O.R. Blue Towels, 18x30 Bulk Non-sterile
00850699008081O.R. Blue Towel Bulk Non-sterile
00850699008890O.R. Towel White Bulk Non-sterile
00850699008883O.R. Towel Green Bulk Non-sterile
00850699008876Green Reusable Towels Bulk Non-sterile
00850699008869Sponge Lap 18x18 X-ray, 800pc/case Bulk Non-sterile
00850699008494Sponge 4x4 12Ply Trach No Xray
00850699008609Lap Sponges, 18x18 w/Ring, 800pc/case Bulk Non-sterile
00850699008562Non-sterile Fluftex Gauze Roll, Lg 400Cs
00850699008555Non-sterile Fluftex Gauze Roll, 600Cs
00850699008548Lap Sponges, 18x18, no loop, 800pc/case Bulk Non-sterile
00850699008517Pad Cover 100/cs
00850699008487Gauze Ball, Cylindrical, Bulk
00850699008456SPONGE, Non-woven, 4PLY, 2X2, banded in 10's, 8000pc/case
00850699008449SPONGE, Non-woven, 4PLY, 3X3, banded in 10's, 4000pc/case
00850699008173Table Cover, 54x54, Non-sterile, 200pcs/case
00850699008814Table Cover, 27x27, 800pc/case
00850699008821Table Cover, 45x45, Non-sterile, 200pc/case
00850699008838Table Cover, 54x72, Non-sterile, 150pcs/case
00850699008845Baby Blanket 30 x 40
00850699008227Cap Bouffant 200/cs
00850699008852SPONGE, Non-woven, 4PLY, 4X4, banded in 10's, 2000pc/case
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