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) EUDAMED21.6 cm Irrigation Clip for 8 mm Diameter Tube. Use with SHORT-HD-G1, SHORT-HD, B-SILVER Attachments. FDA UDI
- Model / Reference
- IRR-CLIP-30 EUDAMEDFDA UDI
- Description
- 21.6 cm Irrigation Clip for 8 mm Diameter Tube. Use with SHORT-HD-G1, SHORT-HD, B-SILVER Attachments. FDA UDI
Identifiers
- Catalog Number
- IRR-CLIP-30 FDA UDI
- Primary DI / UDI-DI
- 00845384002727 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
Yes
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
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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 |
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Manufacturer
- Manufacturer
- Synthes GmbH
- EUDAMED SRN
- CH-MF-000013345
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED a8571b6b-8e63-4e02-bc16-11df7a97d3e4 61 fields · synced Jun 18, 2026
- FDA UDI 19eb9941-2fb5-4ad7-9bc5-24a8a2045eaa 35 fields · synced May 30, 2026