ANSPACH|Irrigation Tubing and Clips
EUDAMEDFDA UDIClass IIa (EU MDR)
by Synthes GmbH
Identity
- Trade Name
- ANSPACH|Irrigation Tubing and Clips EUDAMEDNA FDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- Irrigation Tubing, Irrigation Clips and Hoseclips (Anspach Tubing) EUDAMEDSterile Irrigation High Flow Tube and Clips FDA UDI
- Model / Reference
- IRR-TUBE-HF EUDAMEDFDA UDI
- Description
- Sterile Irrigation High Flow Tube and Clips FDA UDI
Identifiers
- Catalog Number
- IRR-TUBE-HF FDA UDI
- Primary DI / UDI-DI
- 00845384017202 EUDAMEDFDA UDI
- Basic UDI-DI
- 08453840a0022CV EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- Z12130585 MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Surgical irrigation/aspiration tubing set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Spinal shaver system blade
ANSPACH|Irrigation Tubing and Clips by Synthes GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal shaver system blade.
- Disposable Burs — Hicren (Zhejiang) Medtech Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Disposable Burs — Hicren (Zhejiang) Medtech Co., Ltd. · Class IIa
- Disposable Burs — Hicren (Zhejiang) Medtech Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Diamond Abrasor, Ball Tip, Coarse — Joimax GmbH · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08453840a0022CV | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Synthes GmbH
- EUDAMED SRN
- CH-MF-000013345
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED 494831d7-152a-4604-ab03-afe3bff2f779 61 fields · synced Sep 17, 2026
- FDA UDI 456168d5-1698-4475-9088-cd17329dfc44 35 fields · synced May 25, 2026