AccessGUDID - DEVICE: Gyrus ACMI (00821925005204)

GUDID

Device Identifier (DI) Information

Brand Name: Gyrus ACMI
Version or Model: 437A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gyrus ACMI, LLC

Primary DI Number: 00821925005204
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007198742 *Terms of Use

Device Description: Straight Lowsley Tractor Single-Action, Stem Only 21.5 Fr (7.1 mm) With 8 Inch (203 mm) Working Length

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?
32021	Suprapubic catheter introducer, reusable	A rigid surgical instrument(s) intended to gain percutaneous suprapubic access to the urinary bladder, via the lower abdominal wall, for placement of a drainage catheter (not included). It includes a sharp pointed trocar blade and/or a suprapubic access cannula/sleeve, and is typically made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOB	CATHETER, SUPRAPUBIC (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K012153	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 8c5dad16-46ea-4ce7-81c8-b05ef155deb1
Public Version Date: September 02, 2024
Public Version Number: 7
DI Record Publish Date: October 12, 2016