AccessGUDID - DEVICE: Integra® Miltex® (10381780509523)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: PM-4306
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PM-4306
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780509523
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: Joseph Periosteal Elevator, No. 1, 6-3/4", 2mm Wide

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?
38168	Periosteal elevator, reusable	A hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEG	ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

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
No Device Sizes

Device Record Status

Public Device Record Key: d25da24f-3631-43b5-99cc-a73a4f7e0983
Public Version Date: March 25, 2024
Public Version Number: 5
DI Record Publish Date: October 23, 2018