Integra® Miltex®

Primary DI
10381780170112
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
30-CPS7
Catalog number
30-CPS7
Device description
Integra® Miltex® Pessary Cup Size 7 With Support
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHWPESSARY, VAGINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHWPessary, VaginalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013289000BIOTEQUE VAGINAL PESSARIESBioteque America, Inc.2001-12-27HHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780170112PrimaryGS10
H83430CPS71SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178017011210381780170112

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic-organ-supporting pessaryA device made of rubber or soft plastics designed for insertion into the vagina to hold the uterus, bladder and/or rectum in place and help prevent prolapse (falling or sliding of the organ from its normal position into the pelvic cavity), either as a permanent or temporary treatment; it is not dedicated to bladder-only support. It is available in a variety of shapes (e.g., rings, stems) and sizes; it may be fitted for each woman individually. This is a reusable device after appropriate cleaning.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09903124199524CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2026-02-22
15019315015236WallaceICU MEDICAL, INC.HHW2016-10-05
15019315015243WallaceICU MEDICAL, INC.HHW2016-10-05
15019315015250WallaceICU MEDICAL, INC.HHW2016-10-05
15019315015267WallaceICU MEDICAL, INC.HHW2016-10-05
15019315015274WallaceICU MEDICAL, INC.HHW2016-10-05
15019315015281WallaceICU MEDICAL, INC.HHW2016-10-05
15019315015298WallaceICU MEDICAL, INC.HHW2016-10-05
15019315015304WallaceICU MEDICAL, INC.HHW2016-10-05
15019315015311WallaceICU MEDICAL, INC.HHW2016-10-05
15019315015328WallaceICU MEDICAL, INC.HHW2016-10-05
15019315015335WallaceICU MEDICAL, INC.HHW2016-10-05
15019315015342WallaceICU MEDICAL, INC.HHW2016-10-05
10381780169963Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHHW2016-08-26
10381780169970Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHHW2016-08-26
10381780169987Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHHW2016-08-26
10381780169994Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHHW2016-08-26
10381780170006Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHHW2016-08-26
10381780170013Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHHW2016-08-26
10381780170020Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHHW2016-08-26
10381780170037Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHHW2016-08-26
10381780170044Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHHW2016-08-26
10381780170051Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHHW2016-08-26
10381780170068Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHHW2016-08-26
10381780170075Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHHW2016-08-26
10381780170082Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHHW2016-08-26
10381780170099Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHHW2016-08-26
10381780170105Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHHW2016-08-26
10381780170129Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHHW2016-08-26
10381780170136Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHHW2016-08-26