FDA.reportPublic FDA data

Mixing Tips

Primary DI
00386040006166
Brand
Mixing Tips
Company
Gc America Inc.
Model
153012
Catalog number
153012
Device description
Mixing Tips 12 x MIXING TIPS AQUA TYPE 2L NDS
Published
2022-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMATERIAL, IMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955932000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955932000EXAFLEX IMPRESSION MATERIAL (MODIFICATION)GC America, Inc.1996-03-11ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10386040006163PrimaryGS10
00386040006166Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038604000616310386040006163
00386040006166003860400061663860400061660386040006166

GMDN Terms#

Term, Definition table
TermDefinition
Pharmaceutical fluid-dispensing systemA assembly of devices used in a hospital and/or other healthcare facility to dispense fluids by combining in a given ratio several liquid components from a set of source containers into a container with the final product (i.e., it compounds drugs according to a specified medical prescription). It is typically a mains electricity (AC-powered) automated or semi-automated device that includes a set of standardized source liquid containers each attached with tubes to a compounding device which output is in turn attached to the final liquid container. It may also include a control panel to facilitate the introduction of manual or bar-coded mixing and/or checking instructions.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(708)597-0900customerservice@gcamerica.com

Regulatory Flags#

DUNS number
005473608
Device count
12
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14550565002269Cytrans Granules10041295100412952026-03-03
14550565002276Cytrans Granules10041296100412962026-03-03
D047014615Cytrans Granules10041295100412952026-03-03
D047014616Cytrans Granules10041296100412962026-03-03
10386040013437EXA Advanced1381121381122022-08-12
10386040013444EXA Advanced1381131381132022-08-12
10386040013451EXA Advanced1381161381162022-08-12
10386040013468EXA Advanced1381171381172022-08-12
10386040013475EXA Advanced1381181381182022-08-12
10386040013482EXA Advanced1381191381192022-08-12
10386040013871EQUIA®4520034520032022-07-13
D6581200011COE ALGINATE™1200011200012016-08-01
D6581201011COE ALGINATE™1201011201012016-08-01
D6581210011COE ALGINATE™1210011210012016-08-01
D6581211011COE ALGINATE™1211011211012016-08-01
D6581240011COE HYDROPHILIC GEL™1240011240012016-08-01
D6581241011COE HYDROPHILIC GEL™1241011241012016-08-01
D6581310021COE-FLEX®1310021310022016-08-01
D6581310031COE-FLEX®1310031310032016-08-01
D6581310041COE-FLEX®1310041310042016-08-01

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