AccessGUDID - DEVICE: Integra® Miltex® (10381780421788)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 20-360
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-360
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780421788
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Miltex® Faulkner Antrum Curette, 8-1/2", Double-Ended, 7.2mm And 10.4mm Rings, Sharp

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?
47525	Paranasal sinus curette	A slender, hand-held, manual surgical instrument designed for scraping and/or excising tissue from one of the paranasal sinuses (i.e., frontal, sphenoidal, ethmoidal, maxillary). The distal end of the instrument is finished in an appropriate shape (e.g., cup-, ring-, spoon-like) according to the procedure to be performed; the device is typically made of high-grade stainless steel and is available in a variety of shapes and sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAP	CURETTE, NASAL

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: 7.2mm and 10.4mm Rings
Device Size Text, specify: 8-1/2"

Device Record Status

Public Device Record Key: df71988c-7c1a-46b0-ab78-361fc5fdf2d4
Public Version Date: April 27, 2023
Public Version Number: 6
DI Record Publish Date: January 12, 2018