Identity
- Trade Name
- Scanlan® SURG-I-BAND® color coding FDA UDI
- Generic Name
- Surgical instrument track identification tape FDA UDI
- Device Name
- SCANLAN® SURG-I-BAND® color coding EUDAMEDScanlan® SURG-I-BAND® color coding - Narrow, Green (1 spool, approximately 244" x 1/8" wide) FDA UDI
- Model / Reference
- 1001-634 EUDAMEDFDA UDI
- Description
- Scanlan® SURG-I-BAND® color coding - Narrow, Green (1 spool, approximately 244" x 1/8" wide) FDA UDI
Identifiers
- Catalog Number
- 1001-634 FDA UDI
- Primary DI / UDI-DI
- 00846159001310 EUDAMEDFDA UDI
- Basic UDI-DI
- 08461590TF35LG EUDAMED
- FDA Product Code
- FWZ FDA UDI
- EMDN Code
- L80 SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES EUDAMED
- GMDN Term
- Surgical instrument track identification tape FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
SCANLAN® SURG-I-BAND® color coding by Scanlan International Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08461590TF35LG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Scanlan International Inc.
- EUDAMED SRN
- US-MF-000010251
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED fda1d54d-40f1-42b8-a5c0-b96a74c2881a 61 fields · synced Jul 18, 2026
- FDA UDI 350c1856-6bca-4f3d-9425-5f8ff140cf8e 35 fields · synced May 29, 2026