AccessGUDID - DEVICE: Fisherbrand (00613647000731)

GUDID

Device Identifier (DI) Information

Brand Name: Fisherbrand
Version or Model: 15905
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 15905
Company Name: FISHER SCIENTIFIC COMPANY L.L.C.

Primary DI Number: 00613647000731
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004321519 *Terms of Use

Device Description: 1X60 YARD AUTOCLAVE TAPE

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: c22d533a-56e3-45ed-b078-95e15ed783e2
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +018007667000
Email: Regulatory.Affairs@thermofisher.com

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