Question 1

What types of medical devices does Foosin Medical Supplies, Inc. manufacture?

Accepted Answer

Foosin Medical Supplies, Inc. specializes in surgical sutures, offering a range of materials and configurations. Their portfolio includes absorbable sutures like polyglycolic acid (PGA) and bioabsorbable polyester, as well as non-absorbable options such as nylon, silk, and non-absorbable polyester. They also produce polyolefin/fluoropolymer sutures, with variations including monofilament and multifilament designs. These sutures are intended for use in surgical procedures to close wounds or tissues.

Question 2

Where is Foosin Medical Supplies, Inc. based?

Accepted Answer

Foosin Medical Supplies, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.

Question 3

How are Foosin Medical Supplies, Inc.’s devices classified under U.S. regulations?

Accepted Answer

Foosin Medical Supplies, Inc.’s sutures are classified as Class II devices under the U.S. FDA’s regulatory system. This classification applies to devices that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Class II devices often require pre-market notifications (510(k)) to demonstrate substantial equivalence to a predicate device.

Question 4

Are Foosin Medical Supplies, Inc.’s devices listed in any regulatory databases?

Accepted Answer

Yes, Foosin Medical Supplies, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in the supply chain and aiding in post-market surveillance. This listing is part of the company’s compliance with U.S. regulatory requirements.

Question 5

What distinguishes Foosin Medical Supplies, Inc.’s suture products from others in the market?

Accepted Answer

Foosin Medical Supplies, Inc. focuses on a diverse range of suture materials and structures, including both absorbable and non-absorbable options with varying mechanical properties (e.g., monofilament vs. multifilament). Their portfolio covers common surgical needs, such as PGA for tissue approximation that dissolves over time, and durable non-absorbable sutures like nylon and silk for long-term wound closure. The inclusion of specialized materials like polyolefin/fluoropolymer may also address specific clinical requirements, such as reduced tissue reactivity or enhanced knot security.

Device	Model / Reference	Registries	Class	Status
WEGO-PGCL Absorbable Surgical Suture With Needle	Q44193	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	GC1452	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G43203U	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G21402D	FDA UDI	Class II	Unknown
WEGO-PDO Absorbable Surgical Suture With Needle	D51172D	FDA UDI	Class II	Unknown
WEGO-SILK Non-absorbable Surgical Suture With Needle	S34222	FDA UDI	Class II	Unknown
WEGO-Nylon Non-absorbable Surgical Suture With Needle	N46163	FDA UDI	Class II	Active
WEGO-Nylon Non-absorbable Surgical Suture With Needle	N63123	FDA UDI	Class II	Unknown
WEGO-Polyester Nonabsorbable Surgical Suture With Needle	E13403	FDA UDI	Class II	Unknown
WEGO-Nylon Non-absorbable Surgical Suture With Needle	N23363	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P43243	FDA UDI	Class II	Active
WEGO-SILK Non-absorbable Surgical Suture With Needle	SC4319	FDA UDI	Class II	Unknown
WEGO-Nylon Non-absorbable Surgical Suture With Needle	G1006005	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G21302H	FDA UDI	Class II	Unknown
WEGO-PGCL Absorbable Surgical Suture With Needle	QB1262	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	GB3353	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	GB7302	FDA UDI	Class II	Unknown
WEGO-PDO Absorbable Surgical Suture With Needle	D51192	FDA UDI	Class II	Unknown
WEGO-SILK Non-absorbable Surgical Suture With Needle	S23202	FDA UDI	Class II	Unknown
WEGO-Polyester Nonabsorbable Surgical Suture With Needle	EF1402	FDA UDI	Class II	Active
WEGO-SILK Non-absorbable Surgical Suture With Needle	S47173	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G63113U	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G61132U-45	FDA UDI	Class II	Active
WEGO-PDO Absorbable Surgical Suture With Needle	D23262	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G43243*6	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G23363	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	GC1402	FDA UDI	Class II	Active
WEGO-Nylon Non-absorbable Surgical Suture With Needle	N17402	FDA UDI	Class II	Active
WEGO-PGLA Absorbable Surgical Suture With Needle	A2025001	FDA UDI	Class II	Unknown
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P51172	FDA UDI	Class II	Active
WEGO-SILK Non-absorbable Surgical Suture With Needle	S41263	FDA UDI	Class II	Unknown
WEGO-SILK Non-absorbable Surgical Suture With Needle	S31163	FDA UDI	Class II	Unknown
WEGO-Nylon Non-absorbable Surgical Suture With Needle	NC3903	FDA UDI	Class II	Active
WEGO-PGLA Absorbable Surgical Suture With Needle	AB018001	FDA UDI	Class II	Unknown
WEGO-PGLA Absorbable Surgical Suture With Needle	A3004512	FDA UDI	Class II	Unknown
WEGO-PDO Absorbable Surgical Suture With Needle	DB1652P	FDA UDI	Class II	Unknown
WEGO-PDO Absorbable Surgical Suture With Needle	D43192	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G27262	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P43193D	FDA UDI	Class II	Active
WEGO-Polyester Nonabsorbable Surgical Suture With Needle	EB1482	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G41222*4F	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G51083D	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G31262U-70	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G26303	FDA UDI	Class II	Active
WEGO-SILK Non-absorbable Surgical Suture With Needle	S63103	FDA UDI	Class II	Unknown
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P11262	FDA UDI	Class II	Active
WEGO-PGCL Absorbable Surgical Suture With Needle	Q33193V	FDA UDI	Class II	Unknown
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P31302	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P11452	FDA UDI	Class II	Active
WEGO-PGCL Absorbable Surgical Suture With Needle	QB7362	FDA UDI	Class II	Unknown

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