SCANLAN® Minimally-Invasive Instrumentation
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- SCANLAN® Minimally-Invasive Instrumentation FDA UDI
- Generic Name
- Suturing unit, reusable FDA UDI
- Device Name
- SCANLAN® Thoracoscopic Gonzalez-Rivas Knot Pusher EUDAMEDSCANLAN® Thoracoscopic Knot Pusher FDA UDI
- Model / Reference
- 9009-826-14 EUDAMEDFDA UDI
- Description
- SCANLAN® Thoracoscopic Knot Pusher FDA UDI
Identifiers
- Catalog Number
- 9009-826-14 FDA UDI
- Primary DI / UDI-DI
- 00846159034806 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159034806 EUDAMED
- 510(k) Number
- K945474 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Suturing unit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Suturing unit, reusable
SCANLAN® Minimally-Invasive Instrumentation by Scanlan International Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Suturing unit, reusable.
- Hip Suture Grasper — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Suture Manipulator Grasper — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- Knot Manipulator Full Loop — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- HAT-TRICK — Smith & Nephew, Inc. · Class I
Cleared under the same submission
K945474 also covers:
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (2)
- FDA UDI 3cf8ca81-e08a-4b0a-aed6-3bb730e0ae3d 36 fields · synced Jul 17, 2026
- EUDAMED 41921a45-87e9-448e-ad25-7d519f58f486 61 fields · synced Jul 17, 2026