| Primary Device ID | 08906007135849 |
| NIH Device Record Key | 0468c554-a913-47fd-8dc8-b63ae4ca278b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SKORE Bulbous Natural |
| Version Model Number | SKORE Bulbous |
| Company DUNS | 675476406 |
| Company Name | TTK HEALTHCARE LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | +914442008231 |
| kalaivani.b@ttkhealthcare.com | |
| Phone | +914442008231 |
| kalaivani.b@ttkhealthcare.com | |
| Phone | +914442008231 |
| kalaivani.b@ttkhealthcare.com | |
| Phone | +914442008231 |
| kalaivani.b@ttkhealthcare.com | |
| Phone | +914442008231 |
| kalaivani.b@ttkhealthcare.com | |
| Phone | +914442008231 |
| kalaivani.b@ttkhealthcare.com | |
| Phone | +914442008231 |
| kalaivani.b@ttkhealthcare.com | |
| Phone | +914442008231 |
| kalaivani.b@ttkhealthcare.com | |
| Phone | +914442008231 |
| kalaivani.b@ttkhealthcare.com | |
| Phone | +914442008231 |
| kalaivani.b@ttkhealthcare.com | |
| Phone | +914442008231 |
| kalaivani.b@ttkhealthcare.com | |
| Phone | +914442008231 |
| kalaivani.b@ttkhealthcare.com | |
| Phone | +914442008231 |
| kalaivani.b@ttkhealthcare.com | |
| Phone | +914442008231 |
| kalaivani.b@ttkhealthcare.com | |
| Phone | +914442008231 |
| kalaivani.b@ttkhealthcare.com | |
| Phone | +914442008231 |
| kalaivani.b@ttkhealthcare.com | |
| Phone | +914442008231 |
| kalaivani.b@ttkhealthcare.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08906007135832 [Primary] |
| GS1 | 08906007135849 [Package] Contains: 08906007135832 Package: Wallet [3 Units] In Commercial Distribution |
| GS1 | 08906007135856 [Package] Package: Carton [240 Units] In Commercial Distribution |
| GS1 | 08906007135863 [Package] Contains: 08906007135856 Package: Case [2160 Units] In Commercial Distribution |
| HIS | Condom |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-11 |
| Device Publish Date | 2023-07-03 |
| 08906007135764 - SKORE Natural | 2023-07-11 The SKORE Natural condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent male condoms. I |
| 08906007135801 - SKORE Dots Natural | 2023-07-11 The SKORE Dots Natural condom is made of natural rubber latex. It is straight walled, dotted, teat ended, transparent male cond |
| 08906007135849 - SKORE Bulbous Natural | 2023-07-11The SKORE Bulbous Natural condom is made of natural rubber latex. It is straight walled, Bulbous, transparent male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Bulbous Natural, natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases). |
| 08906007135849 - SKORE Bulbous Natural | 2023-07-11 The SKORE Bulbous Natural condom is made of natural rubber latex. It is straight walled, Bulbous, transparent male condoms. It m |
| 08906007135009 - SKORE (Colors & Flavors) | 2023-07-06 The SKORE (Colors & Flavors) condom is made of natural rubber latex. It is straight walled, dotted, teat ended, yellow colored, |
| 08906007135047 - SKORE (Colors & Flavors) | 2023-07-06 The SKORE (Colors & Flavors) condom is made of natural rubber latex. It is straight walled, dotted, teat ended, orange colored, |
| 08906007135085 - SKORE (Colors & Flavors) | 2023-07-06 The SKORE (Colors & Flavors) condom is made of natural rubber latex. It is straight walled, dotted, teat ended, brown colored, C |
| 08906007135122 - SKORE (Colors & Flavors) | 2023-07-06 The SKORE (Colors & Flavors) condom is made of natural rubber latex. It is straight walled, dotted, teat ended, blue colored, Co |
| 08906007135160 - SKORE Smooth Condoms - SKORE (Colors & Flavors) | 2023-07-06 The SKORE Smooth Condoms - SKORE (Colors & Flavors) condom is made of natural rubber latex. It is straight walled, smooth, teat |