Device
ORG-247-01S
Manufacturer
Surgical Design, Inc.
Model: ORG-247-01S DI: 00810189450233 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: Yes
First Published: 2026-05-09 Current Version: 2026-05-18
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: 13a73296-86c0-465b-89ab-6a9b792c0602
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: 00810189450233
Type: Primary
Issuing Agency: GS1
GMDN
Code: 62466
Name: Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Definition:
A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.
FDA Product Codes
GEN
Forceps, General & Plastic Surgery
Device Sizes
Device Size - Size - @attributes - Unit: Inch
Device Size - Size - @attributes - Value: 12
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