Identity
- Trade Name
- SCANLAN® Dilators FDA UDISCANLAN® Needle Holders FDA UDI
- Generic Name
- Vascular dilator, reusable FDA UDISuturing needle holder, reusable FDA UDI
- Device Name
- SCANLAN® Garrett Vascular Dilators EUDAMEDSCANLAN® DeBakey Needle Holder EUDAMEDGarrett Vascular Dilator FDA UDIDeBakey Needle Holder Diamond Dust™ Jaw FDA UDI
- Model / Reference
- 3003-418 EUDAMEDFDA UDI9009-68 FDA UDI
- Description
- Garrett Vascular Dilator FDA UDIDeBakey Needle Holder Diamond Dust™ Jaw FDA UDI
Identifiers
- Catalog Number
- 9009-68 FDA UDI3003-418 FDA UDI
- Primary DI / UDI-DI
- 00846159010657 EUDAMEDFDA UDI00846159003253 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159010657 EUDAMEDB-00846159003253 EUDAMED
- FDA Product Code
- DWP FDA UDIFHQ FDA UDI
- EMDN Code
- L031102 EXPLORATION PROBES, REUSABLE EUDAMEDL0205 NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Vascular dilator, reusable FDA UDISuturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass II FDA UDI
- Regulation Number
- 870.4475 FDA UDI876.4730 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: Vascular dilator, reusable
SCANLAN® Dilators by Scanlan International Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Vascular dilator, reusable.
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- Novo Surgical — NOVO SURGICAL, INC. · Class II
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- HNM MEDICAL — HNM STAINLESS, LLC. · Class I
- Marina Medical — MARINA MEDICAL INSTRUMENTS, 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (4)
- FDA UDI 234c1f4e-2f9b-43c0-98c5-e9d5ae7ff737 35 fields · synced Jul 31, 2026
- FDA UDI 4ca20e3f-dd79-4aa5-887b-2c15c666044c 35 fields · synced May 30, 2026
- EUDAMED 3ed25ce2-2bb7-4499-a054-c23aa6790d87 61 fields · synced Jun 18, 2026
- EUDAMED 7abedfd8-1486-46ad-9f28-aca919b34c1c 61 fields · synced Jul 31, 2026