Model: 1
DI: B356BH414050
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:
03ec5f08-3e5b-4cea-959f-2c7db1075b1a
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:
B356BH414050
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 35131
Name: Amputation knife
Definition:
A hand-held manual surgical instrument with a handle and a heavy single-edged or double-edged blade, of various shapes and sizes, used in surgery for the amputation of a limb. It is typically a one-piece instrument made of high-grade stainless steel. This is a reusable device.
FDA Product Codes
GDN
Knife, Amputation