Identity
- Trade Name
- SCANLAN® Ultra Sharp® FDA UDI
- Generic Name
- General-purpose surgical scissors, reusable FDA UDI
- Device Name
- SCANLAN® Stevens Tenotomy Scissors EUDAMEDStevens Tenotomy Scissors Curved FDA UDI
- Model / Reference
- 7007-315 EUDAMEDFDA UDI
- Description
- Stevens Tenotomy Scissors Curved FDA UDI
Identifiers
- Catalog Number
- 7007-315 FDA UDI
- Primary DI / UDI-DI
- 00846159006711 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159006711 EUDAMED
- FDA Product Code
- LRW FDA UDI
- EMDN Code
- L01040402 VASCULAR SCISSORS, REUSABLE EUDAMED
- GMDN Term
- General-purpose surgical scissors, 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: General-purpose surgical scissors, reusable
SCANLAN® Ultra Sharp® by Scanlan International Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose surgical scissors, reusable.
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- PEAK MEDICAL — PEAK MEDICAL Distribution Inc · Class I
- Iris Scissor (Saw Edge) — Surgicon Private Limited · Class I
- Ambler Value Line — Ambler Surgical, LLC · Class I
- iON — TAKAYAMA INSTRUMENTS INC. · Class I
- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
- Tecomet — Tecomet,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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (2)
- FDA UDI 40b1f7be-44ad-406b-912e-c1bd451f1566 35 fields · synced Jul 31, 2026
- EUDAMED a5b4d755-2f09-4a14-bad8-31f046ef8b31 61 fields · synced Jul 31, 2026