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-PGA Absorbable Surgical Suture With Needle	GB018001	FDA UDI	Class II	Active
WEGO-PGCL Absorbable Surgical Suture With Needle	Q33600	FDA UDI	Class II	Unknown
WEGO-PGLA Absorbable Surgical Suture With Needle	AB1482H	FDA UDI	Class II	Unknown
WEGO-SILK Non-absorbable Surgical Suture With Needle	S21222	FDA UDI	Class II	Unknown
WEGO-Nylon Non-absorbable Surgical Suture With Needle	N66163	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	GB1422	FDA UDI	Class II	Active
WEGO-PDO Absorbable Surgical Suture With Needle	D31202D	FDA UDI	Class II	Active
WEGO-SILK Non-absorbable Surgical Suture With Needle	SB3403	FDA UDI	Class II	Unknown
WEGO-Polyester Nonabsorbable Surgical Suture With Needle	E11262	FDA UDI	Class II	Unknown
WEGO-Nylon Non-absorbable Surgical Suture With Needle	N43263	FDA UDI	Class II	Active
WEGO-SILK Non-absorbable Surgical Suture With Needle	S23273	FDA UDI	Class II	Unknown
WEGO-Nylon Non-absorbable Surgical Suture With Needle	NB3303	FDA UDI	Class II	Unknown
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P11372	FDA UDI	Class II	Active
WEGO-PGLA Absorbable Surgical Suture With Needle	A14303	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G13303	FDA UDI	Class II	Unknown
WEGO-PGCL Absorbable Surgical Suture With Needle	Q11302	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G13502	FDA UDI	Class II	Unknown
WEGO-PDO Absorbable Surgical Suture With Needle	D22362	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G21365	FDA UDI	Class II	Unknown
WEGO-PDO Absorbable Surgical Suture With Needle	DB3363	FDA UDI	Class II	Unknown
WEGO-PGLA Absorbable Surgical Suture With Needle	A2004506	FDA UDI	Class II	Unknown
WEGO-PDO Absorbable Surgical Suture With Needle	D61132	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G43303	FDA UDI	Class II	Active
WEGO-Nylon Non-absorbable Surgical Suture With Needle	N11502HP	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P31162D	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	GB3282	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G31312	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	PB3253	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G2F363U-75	FDA UDI	Class II	Active
WEGO-PGLA Absorbable Surgical Suture With Needle	AB1482	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	GC3482	FDA UDI	Class II	Active
WEGO-Nylon Non-absorbable Surgical Suture With Needle	N11402P	FDA UDI	Class II	Active
WEGO-PGLA Absorbable Surgical Suture With Needle	A13303	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	GB3403	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G68063	FDA UDI	Class II	Active
WEGO-Polyester Nonabsorbable Surgical Suture With Needle	E23482B	FDA UDI	Class II	Active
WEGO-SILK Non-absorbable Surgical Suture With Needle	S21252	FDA UDI	Class II	Unknown
WEGO-PDO Absorbable Surgical Suture With Needle	D31192	FDA UDI	Class II	Unknown
WEGO-Polyester Nonabsorbable Surgical Suture With Needle	E41182D	FDA UDI	Class II	Active
WEGO-SILK Non-absorbable Surgical Suture With Needle	S53193	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P51173	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	PB1302	FDA UDI	Class II	Active
WEGO-SILK Non-absorbable Surgical Suture With Needle	S43223	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	PB3373	FDA UDI	Class II	Active
WEGO-SILK Non-absorbable Surgical Suture With Needle	SB015001	FDA UDI	Class II	Unknown
WEGO-Polyester Nonabsorbable Surgical Suture With Needle	E23303D	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	GB1402D	FDA UDI	Class II	Active
WEGO-PGCL Absorbable Surgical Suture With Needle	Q33192	FDA UDI	Class II	Unknown
WEGO-PGLA Absorbable Surgical Suture With Needle	A27382	FDA UDI	Class II	Unknown
WEGO-Polyester Nonabsorbable Surgical Suture With Needle	E47173	FDA UDI	Class II	Active

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