AccessGUDID - DEVICE: Integra® Ruggles®-Redmond™ (10381780154105)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Ruggles®-Redmond™
Version or Model: R1142
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: R1142
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780154105
Issuing Agency: GS1
Commercial Distribution End Date: December 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: HIBBS TYPE HEMILAMINECTOMY BLADE WITH PRONGS

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?
46774	Surgical retractor/retraction system blade, reusable	A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HBG	DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
No Device Sizes

Device Record Status

Public Device Record Key: dedbd0e3-b7bf-44cd-addd-ded02e2463e5
Public Version Date: March 18, 2024
Public Version Number: 7
DI Record Publish Date: August 11, 2016