Omniflex Diaphragm

Primary DI
00888937001082
Brand
Omniflex Diaphragm
Company
Coopersurgical, Inc.
Model
MXWF95
Device description
Wide-Seal Silicone Vaginal Diaphragm; Size 95
Published
2015-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HDWDiaphragm, Contraceptive (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDWDiaphragm, Contraceptive (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063223000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063223000MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMSCooperSurgical, Inc.2008-01-23HDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937001082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937001082008889370010828889370010820888937001082

GMDN Terms#

Term, Definition table
TermDefinition
Diaphragm pessaryA circular device made of soft rubber or plastic material that is placed in the vagina prior to intercourse to mechanically prevent conception. A spermicidal agent is typically placed within the device to add efficacy. This is a reusable device that should be checked and cleaned before reinsertion.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937027327ER-SpecC0203002026-08-05
00888937027334ER-SpecC0203102026-08-05
00888937027341ER-SpecC0203202026-08-05
00888937027358HER-SpecC0206002026-08-05
00888937027365HER-SpecC0206102026-08-05
00888937027372HER-SpecC0206202026-08-05
00888937027389OfficeSPECC0200012026-08-06
00888937027396HER-SpecC0205002026-08-06
00888937027402HER-SpecC0205102026-08-06
00888937027419HER-SpecC0205202026-08-06
00888937027426ER-SPECC020100-12026-08-06
00888937027433ER-SPECC020110-12026-08-06
00888937027440ER-SpecC020120-12026-08-06
00888937027457ER-SpecC020130-12026-08-06
00888937027464ER-SpecC020140-12026-08-06
00888937027594AnoSPECC0601002026-08-05
00888937027600AnoSPECC0601102026-08-05
00888937027617AnoSPECC0601202026-08-05
00888937032833LifeGlobal® Coda®Incubator UnitGCIU-010-M2026-08-03
00888937032840LifeGlobal® Coda®Filter for Incubator UnitGCIF-001-M2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04013273001649Caya contoured diaphragmKESSEL medintim GmbHHDW2017-11-09
60888937001176MilexCoopersurgical, Inc.HDW2016-09-23
60888937001183MilexCoopersurgical, Inc.HDW2016-09-23
00888937001013Omniflex DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001020Omniflex DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001037Omniflex DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001044Omniflex DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001051Omniflex DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001068Omniflex DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001075Omniflex DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001099Arcing DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001105Arcing DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001112Arcing DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001129Arcing DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001136Arcing DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001143Arcing DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001150Arcing DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001167Arcing DiaphragmCoopersurgical, Inc.HDW2015-12-15