American Medicals

Basic Information

• Brand Name: American Medicals
• Primary DI: B356111PL84312ST0
• Version / Model: 1
• Company Name: American Medicals
• Labeler DUNS: 109909627
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-05
• Public Version: 1
• Public Version Date: 2022-09-13
• Public Version Status: New
• Public Device Record Key: 62b4e6cc-658d-496b-a0c0-042314c265ed

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HXK	Holder, Needle; Orthopedic	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47568	Suturing needle holder, single-use	A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B356111PL84312ST1	HIBCC		25	In Commercial Distribution
Primary	B356111PL84312ST0	HIBCC