Arcing Diaphragm

Primary DI
00888937001129
Brand
Arcing Diaphragm
Company
Coopersurgical, Inc.
Model
MXWS75
Device description
Wide-Seal Silicone Vaginal Diaphragm; Size 75
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
00888937001129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937001129008889370011298889370011290888937001129

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
05060488046858EZ-Strip131µm7-72-1131/202025-04-11
05060488046865EZ-Strip135µm7-72-1135/202025-04-11
05060488046872EZ-Strip145µm7-72-1145/202025-04-11
05060488046889EZ-Strip145µm Long7-72-1145L/202025-04-11
05060488046896EZ-Strip155µm7-72-1170/202025-04-11
05060488046902EZ-Strip170µm7-72-1170/202025-04-11
05060488046919EZ-Strip200µm7-72-1290/202025-04-11
05060488046926EZ-Strip290µm7-72-1290/202025-04-11
05060488046933EZ-Strip290µm7-72-1600/202025-04-11
05060488046940EZ-Tip75µm7-72-2075/12025-04-11
05060488046957EZ-Tip125µm7-72-2125/12025-04-11
05060488046964EZ-Tip135µm7-72-2135/12025-04-11
05060488046971EZ-Tip145µm7-72-2145/12025-04-11
05060488046988EZ-Tip155µm7-72-2155/12025-04-11
05060488046995EZ-Tip170µm7-72-2170/12025-04-11
05060488047008EZ-Tip200µm7-72-2200/12025-04-11
05060488047015EZ-Tip250µm7-72-2250/12025-04-11
05060488047022EZ-Tip290µm7-72/2290/12025-04-11
05060488047039EZ-Tip600µm7-72-2600/12025-04-11
05060488047046EZ-Tip75µm7-72-2075/52025-04-11

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
00888937001082Omniflex DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001099Arcing DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001105Arcing DiaphragmCoopersurgical, Inc.HDW2015-12-15
00888937001112Arcing 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