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SCANLAN® SURG-I-BAND® color coding
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1001-1121
Identity
- Trade Name
- Scanlan® SURG-I-BAND® Color Coding - Data Matrix FDA UDI
- Generic Name
- Surgical instrument track identification tape FDA UDI
- Device Name
- SCANLAN® SURG-I-BAND® color coding EUDAMEDSURG-I-BAND® Color Coding - Data Matrix - Censitrac - Assorted Sizes, Purple FDA UDI
- Model / Reference
- 1001-1121 EUDAMEDFDA UDI
- Description
- SURG-I-BAND® Color Coding - Data Matrix - Censitrac - Assorted Sizes, Purple FDA UDI
Identifiers
- Catalog Number
- 1001-1121 FDA UDI
- Primary DI / UDI-DI
- 00846159032246 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 64a0415d-b4f6-4d45-a868-06ef3fe99fcd 61 fields · synced Jul 17, 2026
- FDA UDI 789907d4-ec00-44a7-aa30-c5eb5fa4efd5 35 fields · synced May 30, 2026