AccessGUDID - DEVICE: Integra® Ruggles®-Redmond™ (10381780458968)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Ruggles®-Redmond™
Version or Model: RN6208
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RN6208
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780458968
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™ Rhoton Style Spatula-Dissector, 7-1/2", 1.9mm Tip, Style No. 8, Large

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?
35343	Brain spatula	A hand-held manual surgical instrument designed to manipulate neural tissue or to remove a material from a neural surface or vessel during brain surgery. It is typically made of high-grade stainless steel and consists of a handle proximally and a broad flat blunt blade (no sharp edges) that can be slightly curved or have various angles at the distal tip, or it can be double-ended. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZX	INSTRUMENT, MICROSURGICAL

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
Device Size Text, specify: 7-1/2"
Width: 1.9 Millimeter

Device Record Status

Public Device Record Key: 4db078f8-a4c9-439b-96a0-d37cbc834e2a
Public Version Date: November 12, 2024
Public Version Number: 4
DI Record Publish Date: March 02, 2018