Identity
- Trade Name
- SCANLAN® Solem™ Vein Holder FDA UDI
- Generic Name
- Surgical soft-tissue manipulation forceps, tweezers-like, single-use FDA UDI
- Device Name
- SCANLAN® Solem™ vein holder EUDAMEDSCANLAN® Solem™ Vein Holder, 6 1/2" / 16.5 cm, Bulk Non-Sterile (5 per pkg) FDA UDISCANLAN® Solem™ Vein Holder, 6 1/2" / 16.5 cm (1 per sterile pkg) FDA UDI
- Model / Reference
- 1001-760 EUDAMEDFDA UDI1001-760B FDA UDI
- Description
- SCANLAN® Solem™ Vein Holder, 6 1/2" / 16.5 cm, Bulk Non-Sterile (5 per pkg) FDA UDISCANLAN® Solem™ Vein Holder, 6 1/2" / 16.5 cm (1 per sterile pkg) FDA UDI
Identifiers
- Catalog Number
- 1001-760B FDA UDI1001-760 FDA UDI
- Primary DI / UDI-DI
- 00846159001068 EUDAMEDFDA UDI00846159027099 FDA UDI
- Basic UDI-DI
- B-00846159001068 EUDAMED
- FDA Product Code
- KDC FDA UDI
- EMDN Code
- C0699 CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Surgical soft-tissue manipulation forceps, tweezers-like, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Surgical soft-tissue manipulation forceps, tweezers-like, single-use
SCANLAN® Solem™ Vein Holder by Scanlan International Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
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 (3)
- FDA UDI c185c080-aa38-4ec9-aa20-752c452950b3 35 fields · synced Jul 22, 2026
- FDA UDI a0922545-bf55-4d91-b551-6b3d4d487115 35 fields · synced May 30, 2026
- EUDAMED 6e4fee5c-1f60-4bd9-9d14-0d91bd625b1b 61 fields · synced Jul 22, 2026