Identity
- Trade Name
- ProteX Safe-Seal FDA UDI
- Generic Name
- Semen specimen collection container FDA UDI
- Device Name
- A sterile, covered, plastic receptacle intended to be used for the collection, preservation, and/or transport of a semen specimen intended for diagnostic and/or therapeutic use including, but not limited to, semen analysis, intrauterine insemination, in vitro fertilization (IVF), and/or intracytoplasmic sperm injection (ICSI). This is a single-use device. The device includes a component to the lid designed to stabilize the sample during transport. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- A sterile, covered, plastic receptacle intended to be used for the collection, preservation, and/or transport of a semen specimen intended for diagnostic and/or therapeutic use including, but not limited to, semen analysis, intrauterine insemination, in vitro fertilization (IVF), and/or intracytoplasmic sperm injection (ICSI). This is a single-use device. The device includes a component to the lid designed to stabilize the sample during transport. FDA UDI
Identifiers
- Catalog Number
- 1PLSS01SRS010000 FDA UDI
- Primary DI / UDI-DI
- B6861PLSS01SRS0100000 FDA UDI
- FDA Product Code
- PUD FDA UDI
- GMDN Term
- Semen specimen collection container FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6160 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
No
FDA UDI
Over-the-Counter
Yes
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
Category: Semen specimen collection container
ProteX Safe-Seal by Rsi Technology Group, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Semen specimen collection container.
- SFG Sperm Collection Container — SPECTRUM FERTILITY GROUP INC. · Class II
- Hy-GeneTM Seminal Fluid Collection Kit — APEX MEDICAL TECHNOLOGIES, INC. · Class II
- Male-FactorPakTM — APEX MEDICAL TECHNOLOGIES, INC. · Class II
- Sperm Collection Container — Vitrolife Sweden AB · Class II
- ProteX — RSI TECHNOLOGY GROUP, LLC · Class II
- ProteX — RSI TECHNOLOGY GROUP, LLC · Class II
- ProteX Safe-Seal — RSI TECHNOLOGY GROUP, LLC · Class II
- ProteX — RSI TECHNOLOGY GROUP, LLC · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Rsi Technology Group, Llc
Sources (1)
- FDA UDI 7fa7c6d1-ef27-4185-b7ff-c8dd07b0651d 35 fields · synced May 30, 2026