AccessGUDID - DEVICE: Fisherbrand (00613647001387)

GUDID

Device Identifier (DI) Information

Brand Name: Fisherbrand
Version or Model: 15901113
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 15901113
Company Name: FISHER SCIENTIFIC COMPANY L.L.C.

Primary DI Number: 00613647001387
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004321519 *Terms of Use

Device Description: Fisherbrand Lead-Free Autoclave Tape 1" x 60 Yard 1 roll

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
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?
43451	Sterility label/tag	A label or tag designed for use prior to, during, and after the process of sterilization of the device it has been attached to for the purpose of indicating that the sterility level required has been achieved. This label/tag can be designed with various built-in indicators that show if the sterility level has been reached or not, e.g., a change in the colour of the label/tag. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JOJ	Indicator, physical/chemical sterilization process

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: ef7f6306-764e-4d50-b73a-f03e957bbaaa
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016