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ITL EssentialsTM Quiver with PVC Loop
EUDAMEDFDA UDIClass I (EU MDR)
Ref A100398
Identity
- Trade Name
- ITL EssentialsTM Quiver with PVC Loop EUDAMEDITL Essential Standard Quiver FDA UDI
- Generic Name
- Electrosurgical handpiece/electrode holder, single-use FDA UDI
- Device Name
- Quiver EUDAMEDStandard quiver, PVC loop, polypropylene, individually packaged and sterile. Device Intended Use: Holder for electrosurgical diathermy system conducting unit and/or other long instruments during surgery. For single use only. FDA UDI
- Model / Reference
- A100398 EUDAMEDFDA UDI
- Description
- Standard quiver, PVC loop, polypropylene, individually packaged and sterile. Device Intended Use: Holder for electrosurgical diathermy system conducting unit and/or other long instruments during surgery. For single use only. FDA UDI
Identifiers
- Catalog Number
- A100398 FDA UDI
- Primary DI / UDI-DI
- 19555240401141 EUDAMEDFDA UDI
- Basic UDI-DI
- 955524040QVRSM8 EUDAMED
- 510(k) Number
- K153472 FDA UDI
- FDA Product Code
- HAM FDA UDI
- EMDN Code
- Z12010999 ELECTROSURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Electrosurgical handpiece/electrode holder, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ITL EssentialsTM Quiver with PVC Loop by Itl Asia Pacific Sdn. Bhd. — 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 | 955524040QVRSM8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ITL Asia Pacific Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000001570
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 2b5af5a0-89bc-45d2-953a-a27ad32cced4 61 fields · synced Jul 26, 2026
- FDA UDI 23b3b5c6-6bff-4e08-8788-d9e11e691353 37 fields · synced May 30, 2026