Question 1

What types of medical devices does Feather Safety Razor Co., Ltd. manufacture?

Accepted Answer

Feather Safety Razor Co., Ltd. specializes in surgical instruments, primarily focusing on ophthalmic and microsurgical tools. Their product line includes single-use and reusable ophthalmic knives, such as disposable and reusable ophthalmic scalpels with plastic or aluminum handles. They also produce reusable manual scalpel blades, single-use scalpels, reusable scalpel handles, reusable general-purpose surgical scissors, and reusable microtome blades for in vitro diagnostics. Some devices, like microsurgical blades for fine incision, are designed for precision applications in surgery.

Question 2

Where is Feather Safety Razor Co., Ltd. based, and where are their devices manufactured?

Accepted Answer

Feather Safety Razor Co., Ltd. is based in the United States. The company’s devices are manufactured domestically, which aligns with regulatory requirements and quality control standards for medical instruments.

Question 3

Which regulatory registries or databases list Feather Safety Razor Co., Ltd.’s devices?

Accepted Answer

Feather Safety Razor Co., Ltd.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify medical devices for regulatory, clinical, and operational purposes, ensuring traceability and compliance with U.S. medical device regulations.

Question 4

How are Feather Safety Razor Co., Ltd.’s devices classified under FDA regulations?

Accepted Answer

Feather Safety Razor Co., Ltd.’s devices fall into two primary FDA classification categories: Class I for lower-risk items and Class II for higher-risk products that require premarket notification (510(k)) clearance. For example, reusable surgical scissors or microtome blades may qualify as Class I, while specialized ophthalmic scalpels or microsurgical blades could be classified as Class II due to their precision and surgical applications.

Question 5

Why are some of Feather Safety Razor Co., Ltd.’s devices listed as single-use while others are reusable?

Accepted Answer

The distinction between single-use and reusable devices depends on factors like sterility, surgical precision, and infection control requirements. Single-use devices, such as disposable ophthalmic scalpels, are designed for one-time use to minimize cross-contamination risks. Reusable devices, like manual scalpel blades or surgical scissors, are engineered for sterilization and repeated use in controlled environments where proper cleaning and sterilization protocols are followed. This classification ensures patient safety and aligns with regulatory expectations for different device types.

Device	Model / Reference	Registries	Class	Status
Feather Disposable Scalpel	No.23	FDA UDI	Class I	Active
Feather Blade Handle For Micro Feather	NF-150S	FDA UDI	Class I	Active
Micro Feather Safeshield Disposable Ophthalmic Scalpel	PSS-7641BR	FDA UDI	Class I	Active
Feather Dissecting Blade	No.62	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.6330G	FDA UDI	Class I	Active
Micro Feather Safeshield Disposable Ophthalmic Scalpel	PSS-722	FDA UDI	Class I	Active
Feather Trimming Knife Handle	F-80P	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-0620RC	FDA UDI	Class I	Active
Feather Blade Handle For Surgical Blade	No.3	FDA UDI	Class I	Active
Feather Blade Handle For Micro Feather	MF-200BA	FDA UDI	Class I	Active
Feather Biopsy Punch	FBP-50	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.7624BUPS	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-722	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-700	FDA UDI	Class I	Active
Feather Surgical Blade Stainless Steel	No.21	FDA UDI	Class I	Active
Chokkin Scissors	Cross Pink	FDA UDI	Class I	Active
MICRO FEATHER MICROSURGICAL BLADE for fine incision	K-28B	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.7625BUPS	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-8630BU	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-7630BUPS	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.7625B	FDA UDI	Class I	Active
Feather Blade Handle For Surgical Blade	No.7	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.7612BU	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.0611RC	FDA UDI	Class I	Active
Micro Feather Safeshield Disposable Ophthalmic Scalpel	PSS-7615BU	FDA UDI	Class I	Active
MICRO FEATHER MICROSURGICAL BLADE for fine incision	K-5600	FDA UDI	Class I	Active
Feather Microtome Blade	S-35 Sample	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.7610BU	FDA UDI	Class I	Active
MICRO FEATHER MICROSURGICAL BLADE for fine incision	K-15L	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.7632B	FDA UDI	Class I	Active
MICRO FEATHER MICROSURGICAL BLADE for fine incision	K-5510	FDA UDI	Class I	Active
Feather Disposable Scalpel	No.10	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-7523	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.06265BUC	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-0618BUC	FDA UDI	Class I	Active
Feather Blade Handle For Micro Feather	MF-100	FDA UDI	Class I	Active
Micro Feather Safeshield Disposable Ophthalmic Scalpel	PSS-0614BUC	FDA UDI	Class I	Active
MICRO FEATHER MICROSURGICAL BLADE for fine incision	K-6410	FDA UDI	Class I	Active
Micro Feather Safeshield Disposable Ophthalmic Scalpel	PSS-7625BUPS	FDA UDI	Class I	Active
Feather Blade Handle For Micro Feather	NF-210B	FDA UDI	Class I	Active
Feather Microtome Blade	High Profile Sample	FDA UDI	Class I	Active
Feather Disposable Scalpel Safeshield Scalpel	No.10	FDA UDI	Class I	Active
Micro Feather Safeshield Disposable Ophthalmic Scalpel	PSS-0622BUC	FDA UDI	Class I	Active
MICRO FEATHER MICROSURGICAL BLADE for fine incision	K-12R	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.722	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-0630BUC	FDA UDI	Class I	Active
Feather Disposable Scalpel	No.12	FDA UDI	Class I	Active
MICRO FEATHER MICROSURGICAL BLADE for fine incision	K-5210	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-7730B	FDA UDI	Class I	Active
Feather Disposable Scalpel Safeshield Scalpel	No.22	FDA UDI	Class I	Active

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