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Scanlan® SUTURE-STATT® suture tags
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 1001-520
Identity
- Trade Name
- Scanlan® SUTURE-STATT® suture tags FDA UDI
- Generic Name
- Vascular booties FDA UDI
- Device Name
- Scanlan SUTURE-STATT® suture tags EUDAMEDScanlan® SUTURE-STATT® suture tags - Suture tag, 2 per sterile package FDA UDI
- Model / Reference
- 1001-520 EUDAMEDFDA UDI
- Description
- Scanlan® SUTURE-STATT® suture tags - Suture tag, 2 per sterile package FDA UDI
Identifiers
- Catalog Number
- 1001-520 FDA UDI
- Primary DI / UDI-DI
- 00846159002362 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159002362 EUDAMED
- FDA Product Code
- KDC FDA UDI
- EMDN Code
- T030101 COVER CAPS, INSTRUMENTS AND EQUIPMENT EUDAMED
- GMDN Term
- Vascular booties 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
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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vascular booties
Scanlan® SUTURE-STATT® suture tags 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
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 |
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Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (2)
- FDA UDI 9e613739-b160-4359-aafa-ee5f89c682e8 35 fields · synced Jun 18, 2026
- EUDAMED 2b72aabe-96a9-4970-bddf-db89f6a2b189 61 fields · synced Jun 18, 2026