AccessGUDID - DEVICE: MTG Pediatric Intermittent Catheter , Coude-tip with hydrophilic low-friction co (00851593006319)

GUDID

Device Identifier (DI) Information

Brand Name: MTG Pediatric Intermittent Catheter , Coude-tip with hydrophilic low-friction co
Version or Model: 81610
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDICAL TECHNOLOGIES OF GEORGIA, INC.

Primary DI Number: 00851593006319
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011005491 *Terms of Use

Device Description: Pediatric Intermittent Catheter, Coude-tip with hydrophilic coating

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:	Yes
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?
45605	Single-administration urethral catheterization kit, single-use	A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBM	Catheter, Urethral

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111405	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry; Keep away from direct sunlight
Storage Environment Temperature: between 33 and 120 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 10 French

Device Record Status

Public Device Record Key: 7af31605-3ee0-43a5-b051-fa13e2ef1719
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 13, 2016