FDA.reportPublic FDA data

Diaphragm Valve Fill Tube and Reflux Valve

Primary DI
10888628006287
Brand
Diaphragm Valve Fill Tube and Reflux Valve
Company
Allergan, Inc.
Model
25-00017
Catalog number
25-00017
Device description
Diaphragm Valve Fill Tube & Reflux Valve
Published
2017-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-FilledGeneral, Plastic Surgery3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888628006287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088862800628710888628006287

GMDN Terms#

Term, Definition table
TermDefinition
Saline-filled breast implant, unstructuredA sterile implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber outer shell, made of polysiloxane(s), with a single lumen inflated with sterile isotonic saline to the desired size. The implant may be of fixed or adjustable volume and may be prefilled, partially filled, or empty and filled during the implantation procedure; the volume of saline solution in adjustable volume implants may be adjusted after implantation. The device may vary in shape, profile, volume, shell surface, and shell thickness.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8006244261ProductSupport@allergan.com

Regulatory Flags#

DUNS number
144796497
Device count
1
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30840228302767SKINVIVE BY JUVEDERM XC 1ML SAMPLE98307DB98307DB2024-04-10
30840228302774JUVEDERM ULTRA PLUS XC 1ML SAMPLE94155DB94155DB2024-04-10
30840228302781JUVEDERM ULTRA XC 1ML SAMPLE94154DB94154DB2024-04-10
30840228302798JUVEDERM VOLBELLA XC 1ML SAMPLE96181DB96181DB2024-04-10
30840228302804JUVEDERM VOLBELLA XC 0.55ML SAMPLE96183DB96183DB2024-04-10
30840228302811JUVEDERM VOLLURE XC 1ML SAMPLE95661DB95661DB2024-04-10
30840228302828JUVEDERM VOLUMA XC 1ML SAMPLE94640DB94640DB2024-04-10
30840228302835JUVEDERM VOLUX XC 1ML SAMPLE20074128200741282024-04-10
30840228300060Skinvive98307983072023-05-22
10888628005907NATRELLE Resterilizable Breast Implant SizersMSZ20120MSZ201202022-10-23
10888628005914NATRELLE Resterilizable Breast Implant SizersMSZ20140MSZ201402022-10-23
10888628005921NATRELLE Resterilizable Breast Implant SizersMSZ20160MSZ201602022-10-23
10888628005938NATRELLE Resterilizable Breast Implant SizersMSZ20180MSZ201802022-10-23
10888628005945NATRELLE Resterilizable Breast Implant SizersMSZ20200MSZ202002022-10-23
10888628005952NATRELLE Resterilizable Breast Implant SizersMSZ20230MSZ202302022-10-23
10888628005969NATRELLE Resterilizable Breast Implant SizersMSZ20260MSZ202602022-10-23
10888628005976NATRELLE Resterilizable Breast Implant SizersMSZ20280MSZ202802022-10-23
10888628005983NATRELLE Resterilizable Breast Implant SizersMSZ20300MSZ203002022-10-23
10888628005990NATRELLE Resterilizable Breast Implant SizersMSZ20325MSZ203252022-10-23
10888628006003NATRELLE Resterilizable Breast Implant SizersMSZ20350MSZ203502022-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07445161001702Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001719Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001726Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001733Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001740Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001757Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001764Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001849Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001856Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001863Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001870Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001887Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001894Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001900Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001917Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001924Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001931Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001948Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001955Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001962Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001979Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002051Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002068Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002075Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002082Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002099Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002105Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002112Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002129Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002136Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04