AccessGUDID - DEVICE: Richard Wolf (00817984011225)

GUDID

Device Identifier (DI) Information

Brand Name: Richard Wolf
Version or Model: 0600-9020-000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0600-9020-000
Company Name: MECTRA LABS, INC.

Primary DI Number: 00817984011225
Issuing Agency: GS1
Commercial Distribution End Date: January 10, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 606939072 *Terms of Use

Device Description: Chip Collection Bottle With Cap

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):	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?
42446	Suction/irrigation system canister/bottle holder, single-use	A device intended to be used to hold a dedicated fluid or collection/specimen canister or bottle that is used within a suction and/or irrigation system. This device can be used to mount the canister/bottle(s) to the parent system when it is mobile (on wheels), or to mount the canister/bottle to a medical device service rail system or a wall rail (typically used on the ward). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAO	INSTRUMENT, SURGICAL, NON-POWERED

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 20 and 115 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 60febee9-067c-46ed-998d-0d8c36c2ab26
Public Version Date: March 22, 2022
Public Version Number: 3
DI Record Publish Date: January 29, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20817984011229	4	00817984011225	2020-01-10	Not in Commercial Distribution	Case
10817984011222	5	00817984011225	2020-01-10	Not in Commercial Distribution	Inner pack