FDA.reportPublic FDA data

Durasphere ® EXP

Primary DI
00858015005004
Brand
Durasphere ® EXP
Company
Carbon Medical Technologies, Inc.
Model
890-215
Catalog number
890-215
Device description
Injectable Bulking Agent
Published
2014-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNMAgent, Bulking, Injectable For Gastro-Urology Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNMAgent, Bulking, Injectable For Gastro-Urology UseUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980053003
P980053004
P980053006
P980053007
P980053008
P980053009
P980053016

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980053003DURASPHERE INJECTABLE BULKING AGENTCarbon Medical Technologies, Inc.1999-09-13LNM
P980053004DURASPHERE INJECTABLE BULKING AGENTCarbon Medical Technologies, Inc.1999-09-13LNM
P980053006DURASPHERE INJECTABLE BULKING AGENTCarbon Medical Technologies, Inc.1999-09-13LNM
P980053007DURASPHERE INJECTABLE BULKING AGENTCarbon Medical Technologies, Inc.1999-09-13LNM
P980053008DURASPHERE INJECTABLE BULKING AGENTCarbon Medical Technologies, Inc.1999-09-13LNM
P980053009DURASPHERE INJECTABLE BULKING AGENTCarbon Medical Technologies, Inc.1999-09-13LNM
P980053016DURASPHERE INJECTABLE BULKING AGENTCarbon Medical Technologies, Inc.1999-09-13LNM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858015005004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858015005004008580150050048580150050040858015005004

GMDN Terms#

Term, Definition table
TermDefinition
Urinary tract reconstructive material, synthetic polymer, non-bioabsorbableA sterile, implantable, non-bioabsorbable synthetic material (e.g., hydrophilic polyacrylamide gel) intended for submucosal injection in the urinary tract (urethra, urinary bladder, and/or distal ureter) to add volume by serving as a space-occupying supplement (bulking agent) to the intercellular matrix of connective tissue in the treatment of stress urinary incontinence (SUI) and/or vesicoureteral reflux (VUR). It is in the form of a gel material typically preloaded in a disposable syringe and is implanted using an endoscope and/or other dedicated instruments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature60 Degrees Fahrenheit90 Degrees Fahrenheit
Special Storage Condition, Specify00Does not require refrigeration

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8882070262info@carbonmed.com

Regulatory Flags#

DUNS number
883094039
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850002461388InjecSURE ®890-313S890-313S2026-04-09
10850002461395InjecSURE ®890-313P890-313P2026-04-09
10850002461418InjecSURE ®890-310S890-310S2026-04-09
10850002461425InjecSURE ®890-310P890-310P2026-04-09
00850002461404InjecSURE ®890-305SS890-305SS2026-04-09
00850002461435InjecSURE®890-305PS890-305PS2026-04-09
00850002461343BiomarC®0401670401672024-07-23
00850002461350Carbon Bright ®0401660401662024-07-23
10850002461340BiomarC®0401670401672024-07-23
10850002461357Carbon Bright ®0401660401662024-07-23
00858015005646BiomarC ® 0401430401432016-10-12
00850002461046Carbon Bright®0401510401512020-01-08
00850002461053Carbon Bright®0401520401522020-01-08
00850002461060Carbon Bright ®0401530401532020-02-18
00850002461077Carbon Bright ®0401540401542020-02-18
00850002461305BIOMARC ® EX0401650401652022-02-07
00858015005059BiomarC®0401400401402015-08-07
00858015005066BiomarC ®0401010401012015-08-18
00858015005073BiomarC ®0401330401332015-08-18
00858015005080BiomarC ®0401420401422015-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810235030645CoaptiteMERZ NORTH AMERICA, INC.LNM2024-10-15
10810005340509BulkamidAXONICS MODULATION TECHNOLOGIES, INC.LNM2023-09-12
10810005340493BulkamidAXONICS MODULATION TECHNOLOGIES, INC.LNM2023-08-30
05704101500500BulkamidContura International A/SLNM2020-03-10
00850004725023Deflux Metal NeedlePALETTE LIFE SCIENCES, INC.LNM2019-02-11
00850004725009DefluxPALETTE LIFE SCIENCES, INC.LNM2019-02-01
00850004725016SolestaPALETTE LIFE SCIENCES, INC.LNM2019-02-01
00365649850035Solesta®SALIX PHARMACEUTICALS, LTD.LNM2014-10-31
00365649922039Deflux®SALIX PHARMACEUTICALS, LTD.LNM2014-10-31
08714729804796CoaptiteMERZ NORTH AMERICA, INC.LNM2014-09-17
00858015005011Durasphere ® EXPCarbon Medical Technologies, Inc.LNM2014-09-17
08717591240266Macroplastique ImplantsUroplasty, Inc.LNM2014-06-20