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-SILK Non-absorbable Surgical Suture With Needle	S13600	FDA UDI	Class II	Unknown
WEGO-PDO Absorbable Surgical Suture With Needle	D41132	FDA UDI	Class II	Unknown
WEGO-Polyester Nonabsorbable Surgical Suture With Needle	E53133	FDA UDI	Class II	Active
WEGO-Polyester Nonabsorbable Surgical Suture With Needle	E21262D	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G11365	FDA UDI	Class II	Unknown
WEGO-SILK Non-absorbable Surgical Suture With Needle	S13353	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G36193-75	FDA UDI	Class II	Active
WEGO-SILK Non-absorbable Surgical Suture With Needle	S43173	FDA UDI	Class II	Active
WEGO-PGLA Absorbable Surgical Suture With Needle	A37172	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	GB1262	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	PB4402	FDA UDI	Class II	Active
WEGO-SILK Non-absorbable Surgical Suture With Needle	S37222	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G33303	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P33243K	FDA UDI	Class II	Active
WEGO-Nylon Non-absorbable Surgical Suture With Needle	N33600	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G78063D	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P43193K	FDA UDI	Class II	Active
WEGO-PGLA Absorbable Surgical Suture With Needle	AB3482H	FDA UDI	Class II	Unknown
WEGO-SILK Non-absorbable Surgical Suture With Needle	S11372	FDA UDI	Class II	Unknown
WEGO-SILK Non-absorbable Surgical Suture With Needle	S61103	FDA UDI	Class II	Unknown
WEGO-Polyester Nonabsorbable Surgical Suture With Needle	E43163	FDA UDI	Class II	Active
WEGO-SILK Non-absorbable Surgical Suture With Needle	S37192	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G31222U	FDA UDI	Class II	Active
WEGO-Nylon Non-absorbable Surgical Suture With Needle	N43650-75	FDA UDI	Class II	Active
WEGO-Polyester Nonabsorbable Surgical Suture With Needle	E31222D	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	GB1442LD	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G43123	FDA UDI	Class II	Active
WEGO-Nylon Non-absorbable Surgical Suture With Needle	N41182	FDA UDI	Class II	Active
WEGO-PDO Absorbable Surgical Suture With Needle	D56163-45	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G13362	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	GB1302H	FDA UDI	Class II	Active
WEGO-PGCL Absorbable Surgical Suture With Needle	Q13372V	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G23202	FDA UDI	Class II	Unknown
WEGO-Nylon Non-absorbable Surgical Suture With Needle	G1025001R	FDA UDI	Class II	Unknown
WEGO-PGLA Absorbable Surgical Suture With Needle	A58084D	FDA UDI	Class II	Unknown
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P23273H	FDA UDI	Class II	Active
WEGO-Polyester Nonabsorbable Surgical Suture With Needle	E33600G	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P71093D	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P31222	FDA UDI	Class II	Active
WEGO-PDO Absorbable Surgical Suture With Needle	D11402H	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G11372*6	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G63123	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P73133	FDA UDI	Class II	Active
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P63163	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	GB1402U	FDA UDI	Class II	Active
WEGO-PGA Absorbable Surgical Suture With Needle	G56133	FDA UDI	Class II	Active
WEGO-PGCL Absorbable Surgical Suture With Needle	Q21362	FDA UDI	Class II	Unknown
WEGO-PGA Absorbable Surgical Suture With Needle	G13372	FDA UDI	Class II	Unknown
WEGO-PGCL Absorbable Surgical Suture With Needle	Q11362V	FDA UDI	Class II	Unknown
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle	P31172D	FDA UDI	Class II	Active

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