Caliber
GUDID 00860013783525
Latex male condom for contraception and prevention of sexually transmitted infections. Lubricated, sterile, single-use, over-the-counter device.
Caliber Brand LLC
Basic male condom, Hevea-latex| Primary Device ID | 00860013783525 |
| NIH Device Record Key | b3d5d6ba-e545-40d8-b6f8-3a2881ee38f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Caliber |
| Version Model Number | 311292518 |
| Company DUNS | 061265830 |
| Company Name | Caliber Brand LLC |
| Device Count | 12 |
| 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 |
Customer Support Contacts
Device Dimensions
| Length | 223 Millimeter |
| Width | 64 Millimeter |
| Length | 223 Millimeter |
| Width | 64 Millimeter |
| Length | 223 Millimeter |
| Width | 64 Millimeter |
| Length | 223 Millimeter |
| Width | 64 Millimeter |
| Length | 223 Millimeter |
| Width | 64 Millimeter |
| Length | 223 Millimeter |
| Width | 64 Millimeter |
| Length | 223 Millimeter |
| Width | 64 Millimeter |
| Length | 223 Millimeter |
| Width | 64 Millimeter |
| Length | 223 Millimeter |
| Width | 64 Millimeter |
| Length | 223 Millimeter |
| Width | 64 Millimeter |
| Length | 223 Millimeter |
| Width | 64 Millimeter |
| Length | 223 Millimeter |
| Width | 64 Millimeter |
| Length | 223 Millimeter |
| Width | 64 Millimeter |
| Length | 223 Millimeter |
| Width | 64 Millimeter |
| Length | 223 Millimeter |
| Width | 64 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860011454847 [Primary] |
| GS1 | 00860013783525 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210208
FDA Product Code
| HIS | Condom |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-03 |
| Device Publish Date | 2025-03-26 |
On-Brand Devices [Caliber]
| 00860011454861 | Latex male condom for contraception and prevention of sexually transmitted infections. Lubricate |
| 00860013783532 | Latex male condom for contraception and prevention of sexually transmitted infections. Lubricate |
| 00860013783525 | Latex male condom for contraception and prevention of sexually transmitted infections. Lubricate |
| 00860013783518 | Latex male condom for contraception and prevention of sexually transmitted infections. Lubricate |
| 00860013783501 | Latex male condom for contraception and prevention of sexually transmitted infections. Lubricate |
| 00860011454892 | Latex male condom for contraception and prevention of sexually transmitted infections. Lubricate |
| 00860011454885 | Latex male condom for contraception and prevention of sexually transmitted infections. Lubricate |
Trademark Results [Caliber]
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