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
Micro Feather Safeshield Disposable Ophthalmic Scalpel	PSS-7632BUPS	FDA UDI	Class I	Active
Feather Surgical Blade Stainless Steel	No.390	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-7519	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.7623BUPS	FDA UDI	Class I	Active
Feather Disposable Scalpel	No.12d	FDA UDI	Class I	Active
Feather Microtome Blade	R-35	FDA UDI	Class I	Active
Feather Surgical Blade Stainless Steel	No.20	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-7610BU	FDA UDI	Class I	Active
MICRO FEATHER MICROSURGICAL BLADE for fine incision	K-30	FDA UDI	Class I	Active
MICRO FEATHER MICROSURGICAL BLADE for fine incision	K-3001	FDA UDI	Class I	Active
Micro Feather Safeshield Disposable Ophthalmic Scalpel	PSS-715	FDA UDI	Class I	Active
Feather Surgical Blade Stainless Steel	No.23	FDA UDI	Class I	Active
Micro Feather Safeshield Disposable Ophthalmic Scalpel	PSS-7926B	FDA UDI	Class I	Active
Feather Blade Handle For Micro Feather	NF-310B	FDA UDI	Class I	Active
MICRO FEATHER MICROSURGICAL BLADE for fine incision	K-745	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.7618BU	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-06275RC	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.7628B	FDA UDI	Class I	Active
Feather Disposable Scalpel	No.20	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.700	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-7618BU	FDA UDI	Class I	Active
MICRO FEATHER MICROSURGICAL BLADE for fine incision	K-5411	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-7630B	FDA UDI	Class I	Active
Chokkin Scissors	Cross Yellow	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-0614RC	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.7520B	FDA UDI	Class I	Active
MICRO FEATHER MICROSURGICAL BLADE for fine incision	K-722	FDA UDI	Class I	Active
Micro Feather Safeshield Disposable Ophthalmic Scalpel	PSS-0616BUC	FDA UDI	Class I	Active
Feather Disposable Scalpel Safeshield Scalpel	No.21	FDA UDI	Class I	Active
Feather Disposable Scalpel Safeshield Scalpel	No.24	FDA UDI	Class I	Active
Chokkin Scissors	Cross Blue	FDA UDI	Class I	Active
Micro Feather Safeshield Disposable Ophthalmic Scalpel	PSS-7726B	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-0622BUC	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.0622RC	FDA UDI	Class I	Active
Feather Dissecting Blade	No.61	FDA UDI	Class I	Active
Feather Trimming Knife Handle	F-130P	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.0630RC	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-7627B	FDA UDI	Class I	Active
MICRO FEATHER MICROSURGICAL BLADE for fine incision	K-5200	FDA UDI	Class I	Active
Micro Feather Safeshield Disposable Ophthalmic Scalpel	PSS-7625B	FDA UDI	Class I	Active
MICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL with plastic handle	P-7651BR	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.0616RC	FDA UDI	Class I	Active
Feather Biopsy Punch	FBP-40	FDA UDI	Class I	Active
Feather Blade Handle For Micro Feather	MF-100BA	FDA UDI	Class I	Active
Feather Blade Handle For Micro Feather	NF-175S	FDA UDI	Class I	Active
Feather Surgical Blade Stainless Steel	No.24	FDA UDI	Class I	Active
MICRO FEATHER MICROSURGICAL BLADE for fine incision	K-50S	FDA UDI	Class I	Active
Micro Feather Safeshield Disposable Ophthalmic Scalpel	PSS-730	FDA UDI	Class I	Active
Feather Surgical Blade Stainless Steel	No.390C	FDA UDI	Class I	Active
MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle	No.7632BUPS	FDA UDI	Class I	Active

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