Device
This device is a sterile, single-use instrument intended to hold suture needles and suture tissues.
Manufacturer
LIVSMED
LIVSMED
Model: ANH02-F
DI: 08800042700843
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
This device is a sterile, single-use instrument intended to hold suture needles and suture tissues.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
fb8aa16d-651c-4053-b49a-b12de0167fa2
Distribution Status:
In Commercial Distribution
DUNS Number:
688360116
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08800042700843
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47568
Name: Suturing needle holder, single-use
Definition:
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.
FDA Product Codes
MDM
Instrument, Manual, Surgical, General Use
Device Sizes
Item #1 - Size - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
8
Item #1 - Size Type:
Outer Diameter
Item #2 - Size - @attributes - Unit:
Centimeter
Item #2 - Size - @attributes - Value:
38
Item #2 - Size Type:
Shaft Length
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling High - @attributes - Value:
80
Item #1 - Storage Handling Type:
Storage Environment Humidity
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
1
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
30
Item #2 - Storage Handling Type:
Storage Environment Temperature