Device
This device is a sterile, single-use instrument intended to ligate soft tissues and blood vessels.
Manufacturer
LIVSMED
LIVSMED
Model: ACA01L-FV
DI: 08800042701406
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 ligate soft tissues and blood vessels.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f1b60c98-0994-4329-9c42-7f615fdf6a36
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:
08800042701406
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65721
Name: Endoscopic surgical ligation clip applier, single-use
Definition:
A hand-held manual surgical instrument intended to be used during an endoscopic (e.g., laparoscopic) surgical procedure to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding (i.e., haemostasis). It is neither designed to apply aneurysm clips nor gastrointestinal clips. It typically includes distal jaws, a slender shaft, and a proximal handle (e.g., trigger-like). The ligation clips are not included. This is a single-use device.
FDA Product Codes
GDO
Applier, Surgical, Clip
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:
Millimeter
Item #2 - Size - @attributes - Value:
450
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