Identity
- Trade Name
- SCANLAN® Knot Pusher FDA UDI
- Generic Name
- Suture knot pusher, reusable FDA UDI
- Device Name
- SCANLAN® CardioVasive™ Chitwood Suture Puller EUDAMEDCardioVasive™ Chitwood Suture Puller FDA UDI
- Model / Reference
- 9009-816 EUDAMEDFDA UDI
- Description
- CardioVasive™ Chitwood Suture Puller FDA UDI
Identifiers
- Catalog Number
- 9009-816 FDA UDI
- Primary DI / UDI-DI
- 00846159011227 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159011227 EUDAMED
- FDA Product Code
- HCF FDA UDI
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Suture knot pusher, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Suture knot pusher, reusable
SCANLAN® Knot Pusher by Scanlan International Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Suture knot pusher, reusable.
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Hayden Medical — Hayden Medical Inc · Class II
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- Closed Knot Pusher — Biomet Orthopedics, Inc. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- MICTEC KNOT PUSHER — SONTEC INSTRUMENTS, INC. · Class II
- V. Mueller — STERIS CORPORATION · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (2)
- FDA UDI c92fcc94-9c1c-4de2-ba90-a32d97fddd93 35 fields · synced Jul 22, 2026
- EUDAMED 97223c37-806a-43a2-b05f-cbfc9c099538 61 fields · synced Jul 22, 2026