AccessGUDID - DEVICE: Medi-Band (00027479270062)

GUDID

Device Identifier (DI) Information

Brand Name: Medi-Band
Version or Model: MBF261216
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MBF261216
Company Name: MEDI-TECH INTERNATIONAL CORPORATION

Primary DI Number: 00027479270062
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 063865158 *Terms of Use

Device Description: Medi-Band Seamless Tubular Band Precut - Size 12 IN x 16 IN

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
10003	Abdominal binder, single-use	A strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISR	Band Or Belt, Pelvic Support

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 32c928ef-f1eb-46c9-a46a-246a479fddaf
Public Version Date: October 07, 2019
Public Version Number: 2
DI Record Publish Date: July 30, 2019