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Lumbar Rod Gripper with Box Ratchet
EUDAMEDFDA UDIClass I (EU MDR)
Ref NoModel LRG-601
Identity
- Trade Name
- Bradshaw Medical FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Lumbar Rod Gripper with Box Ratchet EUDAMEDFDA UDI
- Model / Reference
- LRG-601 EUDAMEDFDA UDINo EUDAMED
- Description
- Lumbar Rod Gripper with Box Ratchet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810019931994 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081001993LRG-601PK EUDAMED
- Direct Marketing DI
- 00810019931994 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0399 GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Lumbar Rod Gripper with Box Ratchet by Bradshaw Medical 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 | 0081001993LRG-601PK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bradshaw Medical Inc.
- EUDAMED SRN
- US-MF-000003392
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 220c326b-1cea-4853-9b90-73db2acbe69e 61 fields · synced Jul 26, 2026
- FDA UDI 8e5c5b8c-3188-44a8-86aa-c89c7e6c2210 33 fields · synced May 26, 2026