Identity
- Trade Name
- SEQUENT EUDAMEDFDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- Orthopedic, Implant, Non-absorbable, Suture Anchor, PEEK, Knee, Sequent EUDAMEDSEQUENT MENISCAL REPAIR DEVICE, CURVED NEEDLE, 7 IMPLANTS FDA UDI
- Model / Reference
- MR007C EUDAMEDFDA UDI
- Description
- SEQUENT MENISCAL REPAIR DEVICE, CURVED NEEDLE, 7 IMPLANTS FDA UDI
Identifiers
- Catalog Number
- MR007C FDA UDI
- Primary DI / UDI-DI
- 20845854015466 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20845854015466 EUDAMED
- 510(k) Number
- K102339 FDA UDI
- FDA Product Code
- MBI FDA UDIGAT FDA UDI
- EMDN Code
- P09120102 ANCHORS, TENDON AND LIGAMENT SYNTHESIS EUDAMED
- GMDN Term
- Suturing unit, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI878.5000 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hand-held surgical retractor, reusable
Sequent by Conmed Corporation — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-20845854015466 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 9e10610f-4060-4068-837d-4e55a14b21a8 61 fields · synced Jun 19, 2026
- FDA UDI fcc446f2-6389-4ecb-a79a-ef658e5b4de9 37 fields · synced May 30, 2026
- EUDAMED 4a9b63c1-3ef5-4a6f-ab04-60607cbcd592 61 fields · synced Jun 19, 2026