Identity
- Trade Name
- CLR EUDAMEDAESCULAP FDA UDI
- Generic Name
- Self-retaining surgical retractor, reusable FDA UDI
- Device Name
- CCR / CLR instrument I EUDAMEDCLR, SLR Retractor (Self Retaining), retractor only, with joint, consisting of TE749R, side loading mechanism, non-sterile, reusable FDA UDI
- Model / Reference
- BW001R EUDAMEDFDA UDI
- Description
- CLR, SLR Retractor (Self Retaining), retractor only, with joint, consisting of TE749R, side loading mechanism, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- BW001R FDA UDI
- Primary DI / UDI-DI
- 04038653222803 EUDAMEDFDA UDI
- Basic UDI-DI
- 4039239000000317ZU EUDAMED
- Direct Marketing DI
- 04038653222803 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L03140101 SELF-STATIC SPREADERS, REUSABLE EUDAMED
- GMDN Term
- Self-retaining surgical retractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
No
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
Clr by Aesculap AG — 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 | 4039239000000317ZU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 1039ec9a-efb6-496d-8740-82bf8f5263e4 61 fields · synced Jul 15, 2026
- FDA UDI 6a1b1a4c-9a79-42e8-a24c-4486fb95ec0c 35 fields · synced May 30, 2026