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-Nylon Non-absorbable Surgical Suture With Needle	N34263	FDA UDI	Class II	Active
WEGO-SILK Non-absorbable Surgical Suture With Needle	SB3373	FDA UDI	Class II	Unknown
WEGO-SILK Non-absorbable Surgical Suture With Needle	S43263	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G46193-75	FDA UDI	Class II	Active
WEGO-Polyester Nonabsorbable Surgical Suture With Needle	E21202DWT	FDA UDI	Class II	Unknown
WEGO-PGLA Absorbable Surgical Suture With Needle	A41152	FDA UDI	Class II	Unknown
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P81063D	FDA UDI	Class II	Active
WEGO-SILK Non-absorbable Surgical Suture With Needle	S51262	FDA UDI	Class II	Active
WEGO-PDO Absorbable Surgical Suture With Needle	D11252	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G21402	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G11402*6	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G14303	FDA UDI	Class II	Unknown
WEGO-SILK Non-absorbable Surgical Suture With Needle	SB4303	FDA UDI	Class II	Unknown
WEGO-Polyester Nonabsorbable Surgical Suture With Needle	EC1402	FDA UDI	Class II	Active
WEGO-PDO Absorbable Surgical Suture With Needle	D3002401	FDA UDI	Class II	Active
WEGO-PGLA Absorbable Surgical Suture With Needle	A21302	FDA UDI	Class II	Unknown
WEGO-Nylon Non-absorbable Surgical Suture With Needle	N41172D	FDA UDI	Class II	Active
WEGO-PDO Absorbable Surgical Suture With Needle	D33303	FDA UDI	Class II	Unknown
WEGO-SILK Non-absorbable Surgical Suture With Needle	SC006013	FDA UDI	Class II	Unknown
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P23302	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P63103	FDA UDI	Class II	Active
WEGO-PDO Absorbable Surgical Suture With Needle	D14222	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G63153	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P57202	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P23262	FDA UDI	Class II	Active
WEGO-PGCL Absorbable Surgical Suture With Needle	Q43193	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	GB025001R	FDA UDI	Class II	Active
WEGO-PDO Absorbable Surgical Suture With Needle	D23273	FDA UDI	Class II	Unknown
WEGO-PGLA Absorbable Surgical Suture With Needle	A41252	FDA UDI	Class II	Unknown
WEGO-Nylon Non-absorbable Surgical Suture With Needle	NC1402	FDA UDI	Class II	Unknown
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	PB3750	FDA UDI	Class II	Active
WEGO-Polyester Nonabsorbable Surgical Suture With Needle	E21162D	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	GB2633	FDA UDI	Class II	Active
WEGO-SILK Non-absorbable Surgical Suture With Needle	S41182	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G23550	FDA UDI	Class II	Active
WEGO-SILK Non-absorbable Surgical Suture With Needle	S4007510	FDA UDI	Class II	Unknown
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P66163	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G21372H	FDA UDI	Class II	Unknown
WEGO-SILK Non-absorbable Surgical Suture With Needle	S23203	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G3015001	FDA UDI	Class II	Active
WEGO-PDO Absorbable Surgical Suture With Needle	DB1482P	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	GB1312	FDA UDI	Class II	Active
WEGO-Nylon Non-absorbable Surgical Suture With Needle	N23193	FDA UDI	Class II	Active
WEGO-PGLA Absorbable Surgical Suture With Needle	A33203	FDA UDI	Class II	Unknown
WEGO-PGLA Absorbable Surgical Suture With Needle	AC004506	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G12643	FDA UDI	Class II	Unknown
WEGO-PDO Absorbable Surgical Suture With Needle	DB1402P	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G21172	FDA UDI	Class II	Unknown
WEGO-Nylon Non-absorbable Surgical Suture With Needle	NB006001	FDA UDI	Class II	Unknown
WEGO-Nylon Non-absorbable Surgical Suture With Needle	G11222	FDA UDI	Class II	Unknown

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