AccessGUDID - DEVICE: Miltex® (10381780038306)

GUDID

Device Identifier (DI) Information

Brand Name: Miltex®
Version or Model: 62-308
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 62-308
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780038306
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: MIXING CUP, STAINLESS WITH PLASTIC LID

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?
45119	Dappen dish, reusable	A small, shallow, hand-held concave vessel made of glass or metal used to mix dental materials chairside prior to application to the patient during dental procedures. The user dispenses the required amount of component materials into the device and mixes them by hand (e.g., with a spatula) until the consistency of the mixture is appropriate. It is most often used for prophy and fluoride treatments, for mixing composite materials, acrylics, cements, and amalgams. 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: 5875ef66-0672-4ce2-8147-150eef86af11
Public Version Date: January 22, 2021
Public Version Number: 5
DI Record Publish Date: September 22, 2015