FDA.reportPublic FDA data

EDGE BIOLOGICALS INC

Primary DI
B6453P240
Brand
EDGE BIOLOGICALS INC
Company
EDGE BIOLOGICALS, INC.
Model
3P240
Device description
MUELLER HINTON AGAR
Published
2023-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/BrothMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132491000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132491000MUELLER HINTON AGAREdge Biologicals, Inc.2014-06-30JTZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B6453P240PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tissue culture/microbiology petri dishA device formed as a round and shallow-sided dish intended to be used to grow and contain tissue and/or microbial cultures for laboratory procedures; it is not intended for in vitro fertilization (IVF). It is designed to fit into a range of laboratory instruments and analysers where various processes can be carried out. The device is typically made of glass or plastic and includes a cover; it may be colour coded. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047927827
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B645GS101EDGE BIOLOGICALS INCGS1012025-04-22
B645GS102EDGE BIOLOGICALS INCGS1022025-04-22
B645GS103EDGE BIOLOGICALS INCGS1032025-04-22
B6450715EDGE BIOLOGICALS INCT07152025-04-21
B6453P395EDGE BIOLOGICALS INC3P3952025-04-21
B645T0415EDGE BIOLOGICALS INCT04152025-04-21
B645T0453EDGE BIOLOGICALS INCT04532025-04-21
B645T0466EDGE BIOLOGICALS INCT04662025-04-21
B645T0481EDGE BIOLOGICALS INCT04812025-04-21
B645T0486EDGE BIOLOGICALS INCT04862025-04-21
B645T0488EDGE BIOLOGICALS INCT04882025-04-21
B645T0496EDGE BIOLOGICALS INCT04962025-04-21
B645T0577EDGE BIOLOGICALS INCT05772025-04-21
B645T0615EDGE BIOLOGICALS INCT06152025-04-21
B645T0641EDGE BIOLOGICALS INCT06412025-04-21
B645T0711EDGE BIOLOGICALS INCT07112025-04-21
B645T0713EDGE BIOLOGICALS INCT07132025-04-21
B645T0714EDGE BIOLOGICALS INCT07142025-04-21
B645T0718EDGE BIOLOGICALS INCT07182025-04-21
B645T0722EDGE BIOLOGICALS INCT07222025-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838090981T8006 Sensititre™ Cation Adjusted Mueller-Hinton w/ TES w/ OADC REMEL, INC.JTZ2025-01-16
00848838020667Sensititre Demineralized WaterREMEL, INC.JTZ2024-02-22
00848838091322Sensititre Saline- Tween w/ Glass BeadsREMEL, INC.JTZ2024-02-22
00848838091360Sensititre Middlebrook 7H9 Broth w/OADCREMEL, INC.JTZ2024-02-22
00848838011177Sensititre Demineralized WaterREMEL, INC.JTZ2023-12-21
00848838008092REMELREMEL, INC.JTZ2022-12-22
00848838008115REMELREMEL, INC.JTZ2022-12-22
00848838011061REMELREMEL, INC.JTZ2022-12-22
00848838013294REMELREMEL, INC.JTZ2022-12-22
00848838012280REMELREMEL, INC.JTZ2022-12-22
15099590655754MicroScanBeckman Coulter, Inc.JTZ2021-06-29
00860003684603Mueller Hinton Agar IINEOGEN CORPORATIONJTZ2020-10-20
00860003684610Mueller Hinton Agar IINEOGEN CORPORATIONJTZ2020-10-20
00860003684627Mueller Hinton Agar IINEOGEN CORPORATIONJTZ2020-10-20
00860003684634Mueller Hinton Agar IINEOGEN CORPORATIONJTZ2020-10-20
00816576023608N/AHARDY DIAGNOSTICSJTZ2020-05-27
00816576023592N/AHARDY DIAGNOSTICSJTZ2020-05-27
10382902211768BD BBL™ Mueller Hinton Agar with 5% Sheep BloodBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902211775BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902212758BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902218002BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902218019BD BBL™ Mueller Hinton Agar with 5% Sheep BloodBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902219528BD BBL™ Oxacillin Screen AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902219931BD BBL™ Mueller Hinton Agar with 5% Sheep BloodBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902219948BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
30382902212752BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
30382902218006BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
30382902219522BD BBL™ Oxacillin Screen AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
30382902219942BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
30382902219935BD BBL™ Mueller Hinton Agar with 5% Sheep BloodBECTON, DICKINSON AND COMPANYJTZ2016-12-21