FDA.report

EDGE BIOLOGICALS INC

Primary DI
B6454P4591
Brand
EDGE BIOLOGICALS INC
Company
EDGE BIOLOGICALS, INC.
Model
4P459
Published
2025-04-17
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
JSGCulture Media, Non-Selective And Non-Differential

Product Code Classifications

CodeDeviceSpecialtyClass
JSGCulture Media, Non-Selective And Non-DifferentialMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B6454P459PrimaryHIBCC0
B6454P4591Unit of UseHIBCC0

GMDN Terms

TermDefinition
Basic/simple nutrient agar culture medium IVDA non-selective, non-differential nutrient agar culture medium containing intended to be used for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen.

Sterilization Methods

Method

Regulatory Flags

DUNS number
047927827
Device count
10
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
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 DIBrandModelCatalogPublished
B645GS101EDGE BIOLOGICALS INCGS1012025-04-22
B645GS102EDGE BIOLOGICALS INCGS1022025-04-22
B645GS103EDGE BIOLOGICALS INCGS1032025-04-22
B64507151EDGE BIOLOGICALS INCT07152025-04-21
B6453P3951EDGE BIOLOGICALS INC3P3952025-04-21
B645GB123EDGE BIOLOGICALS INCGB1232025-04-21
B645MR115EDGE BIOLOGICALS INCMR1152025-04-21
B645SB100DEF1EDGE BIOLOGICALS INCSB100DEF2025-04-21
B645SB50DEF1EDGE BIOLOGICALS INCSB50DEF2025-04-21
B645T04151EDGE BIOLOGICALS INCT04152025-04-21
B645T04531EDGE BIOLOGICALS INCT04532025-04-21
B645T04661EDGE BIOLOGICALS INCT04662025-04-21
B645T04811EDGE BIOLOGICALS INCT04812025-04-21
B645T04861EDGE BIOLOGICALS INCT04862025-04-21
B645T04881EDGE BIOLOGICALS INCT04882025-04-21
B645T04961EDGE BIOLOGICALS INCT04962025-04-21
B645T05771EDGE BIOLOGICALS INCT05772025-04-21
B645T06151EDGE BIOLOGICALS INCT06152025-04-21
B645T06411EDGE BIOLOGICALS INCT06412025-04-21
B645T07111EDGE BIOLOGICALS INCT07112025-04-21

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