Device
1
Manufacturer
American Medicals
Model: 1 DI: B356KB074090 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-05-06 Current Version: 2026-05-14
Sterilization
Method Types - Sterilization Method: Microwave Radiation
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: dc3f4ac5-16c7-498f-9a48-f1c57b5977cd
Distribution Status: In Commercial Distribution
DUNS Number: 109909627
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: No
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: B356KB074090
Type: Primary
Issuing Agency: HIBCC
GMDN
Code: 62466
Name: Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Definition:
A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.
FDA Product Codes
GEN
Forceps, General & Plastic Surgery