FDA.reportPublic FDA data

Caya contoured diaphragm

Primary DI
04013273001649
Brand
Caya contoured diaphragm
Company
KESSEL medintim GmbH
Model
Caya contoured diaphragm
Catalog number
DIA CAYA USA
Device description
Caya Silicone Vaginal Diaphragm for contraception
Published
2017-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

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
K140305000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140305000CAYA CONTOURED DIAPHRAGMKessel Medintim GmbH2014-08-26HDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04013273001649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04013273001649040132730016494013273001649

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.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+496105203720service@medintim.de
1-800-850-1657customerservice@hpsrx.com

Regulatory Flags#

DUNS number
537500365
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04013273000116Active Erection SystemAES 012019-01-21
04013273001557Vagiwell Dilator 5er Set PremiumVagiwell PVagiwell P2023-07-20
04013273001564Vaginal Dilator 3er Set smallVagiwell SVagiwell S2023-07-20
04013273001571Vaginal Dilator 3er Set largeVagiwell LVagiwell L2023-07-20
04013273000208Constriction Ring 9mmRIng 1Ring 12022-07-27
04013273000215Constriction Ring 12mmRIng 2Ring 22022-07-27
04013273000222Constriction Ring 15mmRIng 3Ring 32022-07-27
04013273000239Constriction Ring 18mmRIng 4Ring 42022-07-27
04013273000246Constriction Ring 21mmRIng 5Ring 52022-07-27
04013273001175Manual Erection SystemMES 01MES 012021-11-19
04013273001915Active3 Erection SystemAES 3AES 32020-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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