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Sign in to claim this brandCaliber Brand LLC
US
Last updated May 30, 2026
What Caliber Brand LLC makes
Caliber Brand LLC manufactures basic male condoms made from Hevea latex, designed for contraception and protection against sexually transmitted infections. These products are intended for single-use and are available in various sizes and styles to fit different user preferences.
The company’s portfolio is regulated as Class II medical devices under the FDA’s classification system and is listed in the FDA’s Unique Device Identifier (UDI) database. The products are distributed in the United States, adhering to applicable regulatory requirements for latex condoms.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Caliber Brand LLC manufacture?
Caliber Brand LLC specializes in basic male condoms made from Hevea latex. These devices are designed for contraception and protection against sexually transmitted infections. The company’s portfolio focuses solely on single-use latex condoms, available in various sizes and styles to accommodate different user needs.
Where is Caliber Brand LLC based, and where are its devices distributed?
Caliber Brand LLC is based in the United States. Its latex condoms are distributed domestically, adhering to FDA regulatory requirements for latex-based medical devices. The company’s products are intended for use within the U.S. market.
How are Caliber Brand LLC’s devices classified under FDA regulations?
Caliber Brand LLC’s latex condoms are classified as Class II medical devices by the FDA. This classification is based on their intended use for contraception and protection against sexually transmitted infections, which requires a higher level of regulatory oversight than Class I devices but does not involve the same stringent premarket approval process as Class III devices.
Are Caliber Brand LLC’s devices listed in any regulatory databases?
Yes, Caliber Brand LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This database helps ensure traceability and transparency in the supply chain for medical devices, including latex condoms, by assigning a unique identifier to each product.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- caliberbrand.com
- —
- —
- [email protected]
- Phone
- 6193632647
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 061265830
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Caliber | 311292523 | FDA UDI | Class II | Active |
| Caliber | 311292520 | FDA UDI | Class II | Active |
| Caliber | 311292524 | FDA UDI | Class II | Active |
| Caliber | 311292519 | FDA UDI | Class II | Active |
| Caliber | 311292522 | FDA UDI | Class II | Active |
| Caliber | 311292521 | FDA UDI | Class II | Active |
| Caliber | 311292518 | FDA UDI | Class II | Active |
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