Identity
- Trade Name
- SQ.line® EUDAMEDSQ.LINE FDA UDI
- Generic Name
- Bone file/rasp, manual, reusable FDA UDI
- Device Name
- Raspatorien EUDAMEDSQ.LINE Raspatory, straight, 7 7/8", (200 mm), straight blade, sharp, ergonomic handle, width: 6 mm, non-sterile, reusable FDA UDI
- Model / Reference
- FK318NR EUDAMEDFDA UDI
- Description
- SQ.LINE Raspatory, straight, 7 7/8", (200 mm), straight blade, sharp, ergonomic handle, width: 6 mm, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- FK318NR FDA UDI
- Primary DI / UDI-DI
- 04046955282869 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000003932F EUDAMED
- Direct Marketing DI
- 04046955282869 EUDAMED
- FDA Product Code
- GEG FDA UDI
- EMDN Code
- L091201 ORTHOPAEDIC SURGERY RASPS, REUSABLE EUDAMED
- GMDN Term
- Bone file/rasp, manual, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone file/rasp, manual, reusable
Sq.line by Aesculap, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aesculap, Inc.
Sources (2)
- FDA UDI 6e2f58c3-c77e-4eb7-8698-c97c279d4598 35 fields · synced Oct 8, 2026
- EUDAMED 15c6cc3c-a8e0-4179-9136-1869450c5a37 61 fields · synced Oct 8, 2026