FDA UDI
In Commercial Distribution
🇺🇸 United States
Caya contoured diaphragm
DI: 04013273001649
·
Model: Caya contoured diaphragm
·
KESSEL medintim GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Caya contoured diaphragm
- Primary DI
- 04013273001649
- Version / Model
- Caya contoured diaphragm
- Catalog Number
- DIA CAYA USA
- Company Name
- KESSEL medintim GmbH
- Labeler DUNS
- 537500365
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-09
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 2f61e32f-6e04-4c37-a6e7-5a5761c04996
Device Description
Caya Silicone Vaginal Diaphragm for contraception
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HDW | Diaphragm, Contraceptive (And Accessories) | Obstetrics/Gynecology | 884.5350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42405 | Diaphragm pessary | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04013273001649 | GS1 |
Customer Contacts
- Phone
- 1-800-850-1657
- [email protected]
- Phone
- +496105203720
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140305 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | single size device |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius