AccessGUDID - DEVICE: N/A (04961333244300)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: RS-0004-18
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PENTAX OF AMERICA, INC.

Primary DI Number: 04961333244300
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083211284 *Terms of Use

Device Description: HANDLE FOR 2"/5 CM POST

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?
47081	Endoscope transport trolley tray	A support platform designed as a flat, shallow vessel with a raised rim, that functions as a component of an endoscope transport trolley [i.e., it inserts into the trolley (cart)]. It provides a protective space for the transport and short-term storage of a sterile or contaminated endoscope, endoscope accessories, or other sensitive equipment. It is typically made from plastic materials, is available in a variety of sizes, and may be fitted with a cover lid. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)

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: dbae8368-7bdc-42ae-b2b2-f186c87a9145
Public Version Date: April 16, 2018
Public Version Number: 1
DI Record Publish Date: March 15, 2018

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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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