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Drentech Pump 100 ml Round Drainage w/trocar Fr 10
FDA UDIClass I (US FDA UDI)
by Redax Spa
Identity
- Trade Name
- Drentech Pump 100 ml Round Drainage w/trocar Fr 10 FDA UDI
- Generic Name
- Closed-wound drain, non-bioabsorbable FDA UDI
- Device Name
- The drainage system is composed of a silicone reservoir equipped with an anti-backflow valve and one or two connectors, and a drainage tube. The drainage has depth markings, graduated from the end of the perforated section: these markings facilitate accurate positioning of the drainage in the wound. The silicone drainage is biocompatible and hemocompatible (in accordance with the regulations in force). The subject product is compatible for use with gravity or suction drainage systems. The reservoir has a capacity of 100 ml. Thanks to the typical elasticity of silicone, the drainage suction power remains constant until the reservoir is completely full. The drainage system is a sterile and single-use device. FDA UDI
- Model / Reference
- 10464 FDA UDI
- Description
- The drainage system is composed of a silicone reservoir equipped with an anti-backflow valve and one or two connectors, and a drainage tube. The drainage has depth markings, graduated from the end of the perforated section: these markings facilitate accurate positioning of the drainage in the wound. The silicone drainage is biocompatible and hemocompatible (in accordance with the regulations in force). The subject product is compatible for use with gravity or suction drainage systems. The reservoir has a capacity of 100 ml. Thanks to the typical elasticity of silicone, the drainage suction power remains constant until the reservoir is completely full. The drainage system is a sterile and single-use device. FDA UDI
Identifiers
- Catalog Number
- 10464 FDA UDI
- Primary DI / UDI-DI
- 08034139297095 FDA UDI
- FDA Product Code
- GCY FDA UDI
- GMDN Term
- Closed-wound drain, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4680 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
Yes
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: Closed-wound drain, non-bioabsorbable
Drentech Pump 100 ml Round Drainage w/trocar Fr 10 by Redax Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Closed-wound drain, non-bioabsorbable.
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- Exodus — NAVILYST MEDICAL, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Redax Spa
Sources (1)
- FDA UDI cf5ae28a-5d85-4426-b412-dfc93a6e6e3b 36 fields · synced Jun 1, 2026