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Sign in to claim this brandB BRAUN SURGICAL SA
US
Last updated May 24, 2026
What B BRAUN SURGICAL SA makes
The company produces absorbable and synthetic sutures, including plain catgut sutures for soft tissue approximation, as well as polyolefin/fluoropolymer monofilament sutures for surgical applications. It also manufactures cervical cerclage devices for obstetric support and natural bone wax for hemostasis in surgical procedures.
These devices are classified under FDA’s Class II and Unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
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 B Braun Surgical SA manufacture?
B Braun Surgical SA specializes in surgical materials, including absorbable sutures like plain catgut for soft tissue repair, synthetic monofilament sutures made from polyolefin/fluoropolymer for broader surgical use, cervical cerclage devices to support the cervix during pregnancy, and natural bone wax to control bleeding during procedures. These products are designed for various surgical applications requiring precise tissue handling and hemostasis.
Where is B Braun Surgical SA based, and how does that affect its devices?
B Braun Surgical SA is based in the United States. The company’s location influences regulatory compliance, as its devices must adhere to U.S. standards, including classification under FDA’s categories. The FDA’s Unique Device Identifier (UDI) database lists its products, ensuring traceability and transparency in the medical device supply chain.
How are the devices manufactured by B Braun Surgical SA classified by the FDA?
The devices produced by B Braun Surgical SA fall under two primary FDA classifications: Class II and Unclassified (U). Class II devices generally pose moderate risks and require special controls beyond general controls to ensure safety and effectiveness, while Unclassified devices may require additional review or have unique regulatory pathways depending on their specific use and risk profile.
Which regulatory registries or databases list B Braun Surgical SA’s devices?
B Braun Surgical SA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, which provides a standardized system for identifying medical devices throughout their distribution and use. This registry ensures transparency, traceability, and compliance tracking for healthcare providers and regulators.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- bbraun.com
- —
- —
- [email protected]
- Phone
- +1(800)282-9000
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 511268005
Catalogue (12126)
Page 8 of 243| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Safil Quick+ | G1046441 | FDA UDI | Class II | Unknown |
| Premilene | C2095908 | FDA UDI | Class II | Unknown |
| Novosyn | C0068474 | FDA UDI | Class II | Unknown |
| Dafilon | C0916054 | FDA UDI | Class II | Unknown |
| Silkam | C0772410 | FDA UDI | Class II | Unknown |
| Safil | C1048007 | FDA UDI | Class II | Unknown |
| Silkam | X0765201 | FDA UDI | Class II | Unknown |
| Steelex | C0992046 | FDA UDI | Class II | Unknown |
| Monomax | B0041002 | FDA UDI | Class II | Unknown |
| Softcat | C0651424 | FDA UDI | Class II | Unknown |
| Optilene | C3090422 | FDA UDI | Class II | Unknown |
| Optilene | C3090001 | FDA UDI | Class II | Unknown |
| Optilene | B3095923 | FDA UDI | Class II | Unknown |
| Novosyn | X0069014 | FDA UDI | Class II | Unknown |
| Premilene | G2090780 | FDA UDI | Class II | Unknown |
| Novosyn | B0089796 | FDA UDI | Class II | Unknown |
| Dafilon | C0935204 | FDA UDI | Class II | Unknown |
| Safil | X1048434 | FDA UDI | Class II | Unknown |
| Optilene | C3090256 | FDA UDI | Class II | Unknown |
| Premicron | C2027330 | FDA UDI | Class II | Unknown |
| Silkam | B0266493 | FDA UDI | Class II | Unknown |
| Silkam | X0760927 | FDA UDI | Class II | Unknown |
| Softcat | G0660106 | FDA UDI | Class II | Unknown |
| Dafilon | C0933906 | FDA UDI | Class II | Unknown |
| Safil Quick | C1046240 | FDA UDI | Class II | Unknown |
| Premilene | G0095711 | FDA UDI | Class II | Unknown |
| Premilene | G0090121 | FDA UDI | Class II | Unknown |
| Optilene | C3090446 | FDA UDI | Class II | Unknown |
| Safil Quick | X1046321 | FDA UDI | Class II | Unknown |
| Safil | X1048248 | FDA UDI | Class II | Unknown |
| Monosyn | X0023238 | FDA UDI | Class II | Unknown |
| Novosyn | C0059623 | FDA UDI | Class II | Unknown |
| Premicron | M0026175 | FDA UDI | Class II | Unknown |
| Safil | C1048245 | FDA UDI | Class II | Unknown |
| Novosyn | X0068619 | FDA UDI | Class II | Unknown |
| Novosyn | X0058647 | FDA UDI | Class II | Unknown |
| Novosyn | C0068228 | FDA UDI | Class II | Unknown |
| Dafilon | G1118530 | FDA UDI | Class II | Unknown |
| Novosyn | C0088629 | FDA UDI | Class II | Unknown |
| Premilene | C2090534 | FDA UDI | Class II | Unknown |
| Monoplus | B0024358 | FDA UDI | Class II | Unknown |
| Safil | C1048329 | FDA UDI | Class II | Unknown |
| Safil | C1048464 | FDA UDI | Class II | Unknown |
| Safil | X1038210 | FDA UDI | Class II | Unknown |
| Safil | C1048045 | FDA UDI | Class II | Unknown |
| Safil | G1048090 | FDA UDI | Class II | Unknown |
| Monosyn | C0025119 | FDA UDI | Class II | Unknown |
| Novosyn | C0068021 | FDA UDI | Class II | Unknown |
| Dafilon | C0932998 | FDA UDI | Class II | Unknown |
| Safil | C1049557 | FDA UDI | Class II | Unknown |
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