FDA.reportPublic FDA data

Bulkamid

Primary DI
05704101500500
Brand
Bulkamid
Company
Contura International A/S
Model
50050
Device description
Bulkamid Urethral Bulking System
Published
2020-03-10
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

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
P170023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P170023000Bulkamid Urethral Bulking SystemBoston Scientific Corporation2020-01-28LNM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05704101500500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05704101500500057041015005005704101500500

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various sterile urological surgical instruments and the necessary materials intended to be used to perform a urological surgical procedure. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from direct sunlight
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
308200307
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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
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
00858015005004Durasphere ® EXP Carbon Medical Technologies, Inc.LNM2014-09-17
00858015005011Durasphere ® EXPCarbon Medical Technologies, Inc.LNM2014-09-17
08717591240266Macroplastique ImplantsUroplasty, Inc.LNM2014-06-20