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Scanlan®
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 9009-636Ref 9909-612Ref 9009-642Ref 9009-638Ref 9009-639
Identity
- Trade Name
- SCANLAN® FDA UDISCANLAN® Minimally-Invasive Instrumentation FDA UDISCANLAN® Thoracoscopic Needle holder FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDISuturing needle holder, reusable FDA UDI
- Device Name
- SCANLAN® Thoracoscopic Needle Holder EUDAMEDThoracoscopic Needle Holder FDA UDIThoracoscopic Needle Holder, 7mm, old ring handle, curved carbon inlay jaws, 13.5” / 34 cm FDA UDIThoracoscopic Needle Holder (7mm), (for 2-0 and smaller needles), gold ring handle, straight Carbon-inlay jaws, 16 cm working length, 11-1/4”/28.5 cm total length FDA UDIThoracoscopic Needle Holder (7mm), Ring Handle, gold ring handle, straight carbon-inlay jaws, 16 cm working length, 11-1/4”/28.5 cm total length FDA UDI
- Model / Reference
- 9909-612 EUDAMEDFDA UDI9009-642 EUDAMEDFDA UDI9009-639 EUDAMEDFDA UDI9009-638 EUDAMEDFDA UDI9009-636 EUDAMEDFDA UDI
- Description
- Thoracoscopic Needle Holder FDA UDIThoracoscopic Needle Holder, 7mm, old ring handle, curved carbon inlay jaws, 13.5” / 34 cm FDA UDIThoracoscopic Needle Holder (7mm), (for 2-0 and smaller needles), gold ring handle, straight Carbon-inlay jaws, 16 cm working length, 11-1/4”/28.5 cm total length FDA UDIThoracoscopic Needle Holder (7mm), Ring Handle, gold ring handle, straight carbon-inlay jaws, 16 cm working length, 11-1/4”/28.5 cm total length FDA UDI
Identifiers
- Catalog Number
- 9909-612 FDA UDI9009-642 FDA UDI9009-639 FDA UDI9009-638 FDA UDI9009-636 FDA UDI
- Primary DI / UDI-DI
- 00846159000436 EUDAMEDFDA UDI00846159011173 EUDAMEDFDA UDI00846159025323 EUDAMEDFDA UDI00846159025316 EUDAMEDFDA UDI00846159023404 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159023404 EUDAMEDB-00846159000436 EUDAMEDB-00846159011173 EUDAMEDB-00846159025316 EUDAMEDB-00846159025323 EUDAMED
- 510(k) Number
- K945474 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDISuturing needle holder, 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
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
No
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: Rigid endoscopic tissue manipulation forceps, reusable
Scanlan® by Scanlan International Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscopic tissue manipulation forceps, reusable.
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- Novo Surgical — NOVO SURGICAL, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
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
European Union Unknown
MDD
United States Pending data
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 (10)
- FDA UDI 6efb634b-da47-41b7-b82a-3345a694cd0e 36 fields · synced Sep 18, 2026
- FDA UDI 14acd36e-c37a-4d66-8388-605e9c4f69b5 36 fields · synced May 29, 2026
- FDA UDI 8f8830e2-d5b0-44f9-8c33-e6693962aa8f 36 fields · synced May 30, 2026
- FDA UDI ff29f703-d4af-4e9e-9cb0-bcaf0cab5962 36 fields · synced May 30, 2026
- FDA UDI 344be920-fcf6-43cd-9301-66a5d13dd4a9 36 fields · synced May 30, 2026
- EUDAMED 929ab008-18ff-41d3-ba63-618c01e37849 61 fields · synced Jul 14, 2026
- EUDAMED 1cdd9e76-ebbf-4362-badd-dcf4e5f48f21 61 fields · synced Jul 23, 2026
- EUDAMED f9d4001e-d02c-4e3b-a17e-3f30ce075f31 61 fields · synced Jul 23, 2026
- EUDAMED ebe0a29a-2ba9-4355-9a71-3841434a9524 61 fields · synced Aug 2, 2026
- EUDAMED b26a145f-1c05-4f4b-9199-df7eabbda434 61 fields · synced Sep 18, 2026