Identity
- Trade Name
- DTS-3000 FDA UDI
- Generic Name
- Surgical pneumatic tourniquet system FDA UDI
- Device Name
- DTS Hose EUDAMEDBLUE MAIN HOSE 1ea FDA UDI
- Model / Reference
- 1000190 EUDAMEDFDA UDI
- Description
- BLUE MAIN HOSE 1ea FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809315676519 EUDAMEDFDA UDI
- Basic UDI-DI
- 880931567DTSHOSE5P EUDAMED
- FDA Product Code
- KCY FDA UDI
- EMDN Code
- Z12139080 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical pneumatic tourniquet system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.5910 FDA UDI
- Market of Registration
- Italy 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
Yes
FDA UDI
Category: Surgical pneumatic tourniquet system
Dts-3000 by Daesung Maref Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical pneumatic tourniquet system.
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- Zimmer Tourniquet — RENU MEDICAL, INC · 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
- Manufacturer
- Daesung Maref Co., Ltd.
Sources (2)
- FDA UDI 5de89d70-6d05-47e9-b169-66d7f2ea1699 33 fields · synced Aug 1, 2026
- EUDAMED 0f0a2ba8-e7c1-4fe1-822f-32a74a33b3e8 61 fields · synced Aug 1, 2026