AccessGUDID - DEVICE: Olympus (04042761002974)

GUDID

Device Identifier (DI) Information

Brand Name: Olympus
Version or Model: A2249
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A2249
Company Name: OLYMPUS Winter & Ibe GmbH

Primary DI Number: 04042761002974
Issuing Agency: GS1
Commercial Distribution End Date: October 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 316957240 *Terms of Use

Device Description: Suction tube, for suprapubic overflow controller

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?
47440	Suprapubic needle, reusable	A hand-held manual surgical instrument designed with a sharp pyramidal or conical point at the distal end to percutaneously puncture the lower abdominal wall to provide suprapubic access for surgical repair, typically to position a sling used in the treatment of female stress urinary incontinence (SUI) associated with bladder prolapse. The needle is typically made of a high-grade stainless steel rod (curved or malleable) with a pointed tip and an eye or notch at the distal end to help position the sling. The proximal end can have a handle made of metal or durable plastic. 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 [?]
K904798	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: 62664a48-f125-4d2a-a490-a44ae3d5c4c6
Public Version Date: August 04, 2022
Public Version Number: 6
DI Record Publish Date: September 21, 2016