Device
This device is a sterile, single-use instrument intended to grasp and manipulate tissues.
Manufacturer
LIVSMED
LIVSMED
Model: 5AUD02S-LV
DI: 08800042702816
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 grasp and manipulate tissues.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
51a4261b-1e9b-48fa-8050-573547c986c4
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:
08800042702816
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61839
Name: Rigid endoscopic tissue manipulation forceps, single-use
Definition:
A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. 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:
300
Item #1 - Size Type:
Shaft Length
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
5
Item #2 - Size Type:
Outer Diameter
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
1
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
30
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
80
Item #2 - Storage Handling Type:
Storage Environment Humidity