AccessGUDID - DEVICE: Miltex® (10381780038290)

GUDID

Device Identifier (DI) Information

Brand Name: Miltex®
Version or Model: 62-307
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 62-307
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780038290
Issuing Agency: GS1
Commercial Distribution End Date: March 20, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: SINUS ELEVATOR 2 SINGLE END

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?
35047	ENT elevator	A hand-held, manually-operated, surgical instrument used to lift, position or pry anatomical structures or surgical material during ear/nose/throat (ENT) surgery. It may be a single or a double-ended device with a blunted blade or hook of various shapes with no cutting edges at the distal working end(s) and a handle positioned centrally or at the proximal end. Its shape and size depends upon the intended use, e.g., a blunt antrum, a rhinology or septum elevator, a strong nasal fracture elevator, or a specially designed ear elevator. It is usually made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZL	SCREW, FIXATION, INTRAOSSEOUS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092855	000

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: c2dcf8b7-c6bf-46a9-ba94-b10814ff06ca
Public Version Date: January 22, 2021
Public Version Number: 6
DI Record Publish Date: September 22, 2015