Device
ORG-190S
Manufacturer
Surgical Design, Inc.
Model: ORG-190S DI: 00810055254422 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: Yes
First Published: 2026-04-29 Current Version: 2026-05-07
Sterilization
Item #1: Ethylene Oxide
Item #2: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: ea705539-29f0-4038-b195-b853302f838d
Distribution Status: In Commercial Distribution
DUNS Number: 112617522
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: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00810055254422
Type: Primary
Issuing Agency: GS1
GMDN
Code: 62468
Name: Surgical soft-tissue manipulation forceps, scissors-like, reusable
Definition:
A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.
FDA Product Codes
HTD
Forceps
Device Sizes
Device Size - Size - @attributes - Unit: Inch
Device Size - Size - @attributes - Value: 6.25
Device Size - Size Type: Length
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit: Degrees Fahrenheit
Storage Handling - Storage Handling Low - @attributes - Value: 68
Storage Handling - Storage Handling High - @attributes - Unit: Degrees Fahrenheit
Storage Handling - Storage Handling High - @attributes - Value: 72
Storage Handling - Storage Handling Type: Storage Environment Temperature