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Scanlan® SUTURE BOOT™ Instrument Jaw Covers
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 1001-513Ref 1001-515
Identity
- Trade Name
- Scanlan® SUTURE BOOT™ Instrument Jaw Covers FDA UDI
- Generic Name
- Vascular booties FDA UDI
- Device Name
- Scanlan SUTURE BOOT™ instrument jaw covers EUDAMEDSUTURE BOOT™ instrument jaw covers EUDAMEDScanlan® SUTURE BOOT™ Instrument Jaw Covers - Large Pink, mini pkg, BNS (600 per bag) FDA UDIScanlan® SUTURE BOOT™ Instrument Jaw Covers - Original Yellow, mini pkg (3 pair/cartridge, 1 cartridge/pkg) FDA UDIScanlan® SUTURE BOOT™ Instrument Jaw Covers - Large Pink, mini pkg (3 pair/cartridge, 1 cartrid/pkg) FDA UDI
- Model / Reference
- 1001-513 EUDAMEDFDA UDI1001-515 EUDAMEDFDA UDI1001-515BX FDA UDI
- Description
- Scanlan® SUTURE BOOT™ Instrument Jaw Covers - Large Pink, mini pkg, BNS (600 per bag) FDA UDIScanlan® SUTURE BOOT™ Instrument Jaw Covers - Original Yellow, mini pkg (3 pair/cartridge, 1 cartridge/pkg) FDA UDIScanlan® SUTURE BOOT™ Instrument Jaw Covers - Large Pink, mini pkg (3 pair/cartridge, 1 cartrid/pkg) FDA UDI
Identifiers
- Catalog Number
- 1001-515BX FDA UDI1001-513 FDA UDI1001-515 FDA UDI
- Primary DI / UDI-DI
- 00846159001112 EUDAMEDFDA UDI00846159001129 EUDAMEDFDA UDI00846159028416 FDA UDI
- Basic UDI-DI
- B-00846159001112 EUDAMEDB-00846159001129 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 UDIFDA 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
Radiation Sterilization FDA UDI
Category: Vascular booties
Scanlan® SUTURE BOOT™ Instrument Jaw Covers 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 (5)
- FDA UDI 9b103752-8929-4c82-a3ab-69d5d70c4458 35 fields · synced Aug 3, 2026
- FDA UDI 6988843d-1e97-40c5-b74e-d47cc60dda57 35 fields · synced May 29, 2026
- FDA UDI 43fa6270-3624-44ff-ab42-3f0f4c62b5e5 35 fields · synced May 29, 2026
- EUDAMED b9ad2d54-5ba3-4873-8f77-b9c7e401190a 61 fields · synced Jul 30, 2026
- EUDAMED f42910c2-c818-49d4-8ea5-99300a5a1a75 61 fields · synced Aug 3, 2026