Palatal Retractor
by Avalign Technologies Inc. 20 variants
Ref 03.520.002, 48970058, 10-6503-220-02, 89000-12, 42-2206, 42-2105, 48970003, 10-5503-222-01, 48920019, 48970004, 42-2102, 10-5503-182-01, 48970002, 42-2104, 42-2107, 48920021, 89000-03-020, 89000-04-010, 42-2103, 48920001, 48920002, 42-2207
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0190776RETRACT2N | Date4 Dec 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00190776028152 | Date16 Aug 2018 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- OrthofixAlphatec SpineStrykerStryker SpineDepuy Synthes
- Generic Name
- Bone lever/elevator, reusableNerve/vessel retractorSelf-retaining surgical retractor, reusableSoft-tissue surgical hook, reusable
- Device Name
- Palatal Retractor
- Model / Reference
- 03.520.002, 10-5503-222-01, 89000-04-010, 10-5503-182-01, 42-2103, 89000-12, 48970004, 42-2206, 10-6503-220-02, 48970002, 48920001, 48920002, 48920019, 48920021, 48970003, 42-2107, 42-2104, 42-2102, 89000-03-020, 42-2105, 42-2207, 48970058, 48970059
- Description
- 22mm Cobb Elevator, UpBAYONET RETRACTOR18mm Cobb Elevator, UpADJUSTABLE VERTEBRAL BODY RETRACTOR, 20mmRIB STRIPPER ELEVATORStraight Cobb, 26mmPenfield Reverse 4mm, BayonetedCURVED ELEVATOR, 6mm22mm Cobb ElevatorStraight Cobb, 18mm15mm Adjustable Vertebral Body Retractor20mm Adjustable Vertebral Body Retractor10mm Retractor14mm RetractorStraight Cobb, 22mmBAYONET RETRACTOR, 14mmADJUSTABLE VERTEBRAL BODY RETRACTOR, 30mmADJUSTABLE VERTEBRAL BODY RETRACTOR, 15mmADJUSTABLE VERTEBRAL BODY RETRACTORDouble Hook Skin Retractor, 2mmBAYONET RETRACTOR, 10mmCURVED ELEVATOR, 10mmPenfield 4mm, Bayonetted
- Primary DI / UDI-DI
- 00190776028152, 00190776124465, 00190776124441, 00190776149093, 00190776149062, 00190776140441, 00190776140991, 00190776149338, 00190776128173, 00190776140427, 00190776148591, 00190776148607, 00190776148775, 00190776148799, 00190776140434, 00190776149130, 00190776149109, 00190776149086, 00190776148829, 00190776149116, 00190776149345, 00190776140984, 10190776148840, 00190776148843
- Basic UDI-DI
- 0190776RETRACT2N
- Direct Marketing DI
- 0019077602815200190776140991001907761281730019077614906200190776149338001907761491160019077614043400190776124465001907761487750019077614044100190776149086001907761244410019077614098400190776140427001907761491090019077614913000190776148799001907761488291019077614884000190776149093001907761485910019077614860700190776149345
- FDA Product Code
- GEG, GAD, GDG
- EMDN Code
- L03140199, L0902
- GMDN Term
- Bone lever/elevator, reusableNerve/vessel retractorSelf-retaining surgical retractor, reusableSoft-tissue surgical hook, reusable
- Device Class
- Class I
- Regulation Number
- 878.4800
- EU market of registration
- Bulgaria
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
- Size
- Width — 10 MillimeterWidth — 20 Millimeter
Manufacturer details
- EUDAMED SRN
- US-MF-000008511
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from AVALIGN TECHNOLOGIES, Inc.
Properties
Other properties (19)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No