AccessGUDID - DEVICE: NA (04546540898562)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 0300040000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0300-040-000
Company Name: STRYKER CORPORATION

Primary DI Number: 04546540898562
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: Bucket Liners

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?
12223	Bucket liner	A device used to line a bucket in order to create a barrier to contamination and serve as the basis for preventing cross-contamination, reducing cleaning requirements, and protecting the bucket surface finish. This liner will typically be used in swab buckets, commonly known as kick buckets. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGG	INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL

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: 20bf08ba-2429-4b8b-87a9-3c10b84c263a
Public Version Date: September 27, 2021
Public Version Number: 2
DI Record Publish Date: September 24, 2018