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SCANLAN® TIP-GUARD™ instrument protectors
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1001-405
Identity
- Trade Name
- Scanlan® TIP-GUARD™ instrument protectors - Vented FDA UDI
- Generic Name
- Surgical instrument guard, reusable FDA UDI
- Device Name
- SCANLAN® TIP-GUARD™ instrument protectors EUDAMEDScanlan® TIP-GUARD™ instrument protectors - Vented - Tinted, Black Tinted, 3.2 x 25.4 x 25.4 mm (100 pieces per package) FDA UDI
- Model / Reference
- 1001-405 EUDAMEDFDA UDI
- Description
- Scanlan® TIP-GUARD™ instrument protectors - Vented - Tinted, Black Tinted, 3.2 x 25.4 x 25.4 mm (100 pieces per package) FDA UDI
Identifiers
- Catalog Number
- 1001-405 FDA UDI
- Primary DI / UDI-DI
- 00846159002188 EUDAMEDFDA UDI
- Basic UDI-DI
- 08461590TF21L5 EUDAMED
- FDA Product Code
- FWZ FDA UDI
- EMDN Code
- L80 SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES EUDAMED
- GMDN Term
- Surgical instrument guard, reusable 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
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
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
SCANLAN® TIP-GUARD™ instrument protectors 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 | 08461590TF21L5 | 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 aaacd23c-7610-48d0-9bc4-4372bb742a62 61 fields · synced Jul 9, 2026
- FDA UDI 057fcf81-73d6-4158-baf5-1265a976ed5f 35 fields · synced May 30, 2026