AccessGUDID - DEVICE: Miltex® (10381780038245)

GUDID

Device Identifier (DI) Information

Brand Name: Miltex®
Version or Model: 62-300
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 62-300
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780038245
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: DENTAL MEMBRANE TACK KIT

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:	Yes
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?
46645	Dental regeneration membrane fixation tack, non-bioabsorbable	A non-bioabsorbable tack intended to be driven into bone to fix or stabilize bioabsorbable barrier membranes used for the regeneration of tissue and/or bone in the oral cavity, or used for other clinical situations that require membrane utilization. The device is typically made of metal (e.g., titanium alloy). This is a single-use 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: 87844e4b-d9f4-40ed-bde0-56cec2f085c7
Public Version Date: June 12, 2024
Public Version Number: 7
DI Record Publish Date: September 22, 2015