Identity
- Trade Name
- Disposable Distal Tip Protectors FDA UDI
- Generic Name
- Endoscope transport/sterilization protective cover, single-use FDA UDI
- Model / Reference
- FTL-DTP-M-L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936603225745 FDA UDI
- FDA Product Code
- MNL FDA UDI
- GMDN Term
- Endoscope transport/sterilization protective cover, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscope transport/sterilization protective cover, single-use
Disposable Distal Tip Protectors by Yangzhou Fartley Medical Instrument Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Endoscope transport/sterilization protective cover, single-use.
- Scope Tip Protector — Micro-tech Usa · Class I
- Scope Tip Protector — Micro-tech Usa · Class I
- Disposable Distal Tip Protectors — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
Sources (2)
- FDA UDI acbd8640-4b24-4a5d-903d-c3161b8c34f3 32 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026