AccessGUDID - DEVICE: Integra® Ruggles®-Redmond™ (10381780202875)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Ruggles®-Redmond™
Version or Model: RN7023
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RN7023
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780202875
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Ruggles®-Redmond™ Kurze Dissecting Scissors, Curved Right

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13496	Neurosurgical scissors	A hand-held manual surgical instrument designed to cut tissue (e.g., dura mater, neural soft-tissue) during neurosurgery. It comprises two hinged blades of micro design that cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of metal and is available in various designs. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAO	INSTRUMENT, SURGICAL, NON-POWERED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 8.5 Millimeter
Device Size Text, specify: 5-1/2"

Device Record Status

Public Device Record Key: d8e0d60b-114d-42ac-9fb2-0bdee85ec44f
Public Version Date: April 10, 2024
Public Version Number: 5
DI Record Publish Date: April 02, 2018