Device
ORG-215S
Manufacturer
Surgical Design, Inc.
Model: ORG-215S DI: 00810055254583 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: Yes
First Published: 2026-05-06 Current Version: 2026-05-14
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: ccb8a92f-6e84-44d6-bd27-d904d10f4db8
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: 00810055254583
Type: Primary
Issuing Agency: GS1
GMDN
Code: 34961
Name: Towel clamp, reusable
Definition:
A surgical instrument designed to hold together surgical towels and/or drapes, or for securing other devices such as cables/leads, during an operation/intervention. It is made of metallic or polymer materials and is available in a variety of sizes and designs (e.g., two blades joined at their midpoints, single alpha-shaped device, various gripping jaws); it is commonly known as a towel clamp, towel forceps, or towel clip. This is a reusable device.
FDA Product Codes
GDJ
Clamp, Surgical, General & Plastic Surgery
Device Sizes
Device Size - Size - @attributes - Unit: Inch
Device Size - Size - @attributes - Value: 5.25
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