Question 1

What types of medical devices does Pharma Sept Medical Products manufacture?

Accepted Answer

Pharma Sept Medical Products specializes in single-use protective drapes and coverings for medical equipment. Their products include microscope drapes tailored for specific brands like Zeiss and Leica, as well as covers for video cameras, C-arms, and X-ray imaging systems. These items are designed to maintain sterility and prevent contamination during medical procedures.

Question 2

Where is Pharma Sept Medical Products based?

Accepted Answer

The company is based in the United States. This location aligns with its focus on compliance with U.S. medical device regulations, including registration in the FDA’s Unique Device Identifier (UDI) database.

Question 3

Which regulatory registries list Pharma Sept Medical Products’ devices?

Accepted Answer

Pharma Sept Medical Products’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures traceability and compliance for medical devices in the U.S., helping track and monitor products throughout their lifecycle.

Question 4

How are Pharma Sept Medical Products’ devices classified under U.S. regulations?

Accepted Answer

All of Pharma Sept Medical Products’ listed devices fall under Class I regulatory classification in the U.S. This classification means they are subject to general controls, such as good manufacturing practices and labeling requirements, but do not require pre-market approval. Class I devices are typically considered low-risk.

Device	Model / Reference	Registries	Class	Status
Microscope Cover MITAKA mm80, mm90, 80/276	MU8190HRSN	FDA UDI	Class I	Active
Microscope Cover MITAKA mm80, mm90, 80/266	MU8090HRSN	FDA UDI	Class I	Active
Microscope Cover LEICA 115/300, 7 HLT	VMD80-4518	FDA UDI	Class I	Active
Microscope Cover LEICA 115/210 W/DRAWSTRING HLT	VMD90-4580DS	FDA UDI	Class I	Active
Microscope Cover ZEISS 137/380 6.50 HLT	VMD90-5449	FDA UDI	Class I	Active
Olympus Drape 115x260 5.8 Hlt	8560H	FDA UDI	Class I	Active
Microscope Cover, w/Rubber Bands, 137cm x 380cm, 54" x 150" 7.0	7420HCR	FDA UDI	Class I	Active
Mitaka MM51 cover	80-573H	FDA UDI	Class I	Active
Microscope Cover LEICA 115/300 10.50	8235	FDA UDI	Class I	Active
Microscope Cover ZEISS "OPMI" 115/180 4.85	8214	FDA UDI	Class I	Active
Image Cover 36R	5002	FDA UDI	Class I	Active
Microscope Cover ZEISS "MD" 115/180 6.50 HLT	9266H	FDA UDI	Class I	Active
Microscope Cover, w/Rubber Bands, 115cm x 300cm, 45" x 118" 7.0	7228HCR	FDA UDI	Class I	Active
Microscope Cover ZEISS 137/380 6.50	8430	FDA UDI	Class I	Active
X-Ray Cassette Cover	5120	FDA UDI	Class I	Active
Microscope Cover ZEISS "MD" 115/260 6.50	8276	FDA UDI	Class I	Active
Protective Cover 95/75cm with Adhesive	5052A	FDA UDI	Class I	Active
C-Arm Cover UNIVERSAL 112/183	4444	FDA UDI	Class I	Active
Microscope Cover ZEISS "MD" 115/300 6.50 HLT	9296H	FDA UDI	Class I	Active
Microscope Cover MITAKA 137/380 HLT	MU8090HRW	FDA UDI	Class I	Active
Microscope Cover ZEISS "MD" 137/330 6.50 HLT	8432H	FDA UDI	Class I	Active

PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.

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