Device
ORG-179S
Manufacturer
Surgical Design, Inc.
Model: ORG-179S DI: 00810055254378 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: Yes
First Published: 2026-04-28 Current Version: 2026-05-06
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: a3781be7-1ed2-4a00-94dc-d31997eeb8c7
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: 00810055254378
Type: Primary
Issuing Agency: GS1
GMDN
Code: 62467
Name: Surgical soft-tissue manipulation forceps, alligator, reusable
Definition:
A long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.
FDA Product Codes
HTD
Forceps
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