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LEE No.7 DISSECTOR, DOUBLE-ENDED
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 6.80.07Model ENT Manual Reusable Surgical Instruments
Identity
- Trade Name
- LEE NO. 7 DISSECTOR, DOUBLE-ENDED, 3 MM AND 5 MM BLADES EUDAMEDLEE No.7 DISSECTOR, DOUBLE-ENDED FDA UDI
- Generic Name
- Open-surgery dissector FDA UDI
- Device Name
- LEE NO. 7 DISSECTOR, DOUBLE-ENDED, 3 MM AND 5 MM BLADES FDA UDI
- Model / Reference
- 6.80.07 EUDAMEDFDA UDIENT Manual Reusable Surgical Instruments EUDAMED
- Description
- LEE NO. 7 DISSECTOR, DOUBLE-ENDED, 3 MM AND 5 MM BLADES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844505012201 EUDAMEDFDA UDI
- Basic UDI-DI
- 08445050024LJ EUDAMED
- Direct Marketing DI
- 00844505012201 EUDAMED
- FDA Product Code
- LRC FDA UDI
- EMDN Code
- L149011 ENT SURGERY DISSECTORS, REUSABLE EUDAMED
- GMDN Term
- Open-surgery dissector FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4420 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: Open-surgery dissector
LEE No.7 DISSECTOR, DOUBLE-ENDED by Grace Medical, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Open-surgery dissector.
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- Ambler Surgical — Ambler Surgical, LLC · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
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
- Grace Medical, Inc.
Sources (2)
- FDA UDI 8d76ddfe-2de9-490d-8a95-3d7edf3f49e7 34 fields · synced Jul 12, 2026
- EUDAMED 2aa073c6-f96f-499f-88d6-f08c1073d3ef 61 fields · synced Jul 12, 2026