FDA.reportPublic FDA data

Omniflex Diaphragm

Primary DI
00888937001037
Brand
Omniflex Diaphragm
Company
Coopersurgical, Inc.
Model
MXWF70
Device description
Wide-Seal Silicone Vaginal Diaphragm, Size 70
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
00888937001037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937001037008889370010378889370010370888937001037

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
00888937033687ONETRACC1001502026-07-10
00888937033694ONETRACC1001652026-07-10
00888937033700ONETRACC1001702026-07-10
00888937033717ONETRACC1001802026-07-10
00888937033724ONETRACC1001902026-07-10
00888937033731ONETRAC LXC1002102026-07-10
00888937033748ONETRAC LXC1002202026-07-10
00888937033755ONETRAC LXC1002302026-07-10
00888937033762ONETRAC LXC1002402026-07-10
00888937033779ONETRAC LXC1002502026-07-10
00888937033786ONETRAC™ LXSC1002602026-07-10
00888937033793ONETRAC™ LXSC1002702026-07-10
00888937033809ONETRAC™ LXSC1002802026-07-10
00888937033816ONETRAC™ LXSC1002902026-07-10
00888937033823ONETRAC™ LXSC1102002026-07-10
00888937033830ONETRAC™ LXSC1102102026-07-10
00888937033847ONETRAC™ LXSC1102202026-07-10
00888937033854ONETRAC™ LXSC1103102026-07-10
00888937033861ONETRAC™ LXSC1103202026-07-10
00888937033663ONETRAC™C1001102026-07-09

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
00888937001044Omniflex DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001051Omniflex DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001068Omniflex DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001075Omniflex DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001082Omniflex 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