AccessGUDID - DEVICE: Integra® Miltex® (10381780360131)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 14-10-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 14-10-10
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780360131
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Miltex® Bakes Common Duct Dilator, 8-1/2", 10mm Diameter

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?
11256	Common bile duct dilator	A hand-held manual surgical instrument designed to dilate the common bile duct, i.e., the union of the cystic and hepatic ducts. It typically consists of a slender hollow or solid body instrument made of metal or plastic in a cylindrical form. It is available in a variety of sizes (diameters) and flexibilities. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGM	PROBE AND DIRECTOR, GASTRO-UROLOGY

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: a3cbee11-ead2-4ddd-a4d2-789d678ad729
Public Version Date: April 26, 2023
Public Version Number: 5
DI Record Publish Date: June 28, 2017