AccessGUDID - DEVICE: Suprapubic Introducer (00890594000223)

GUDID

Device Identifier (DI) Information

Brand Name: Suprapubic Introducer
Version or Model: CAL-SP01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CAL-SP01
Company Name: Caldera Medical, Inc.

Primary DI Number: 00890594000223
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 130341956 *Terms of Use

Device Description: Suprapubic Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion and placement of Desara surgical mesh.

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
PWJ	Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172614	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
Special Storage Condition, Specify: Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c8a40869-4adc-4747-b43f-f2b7a2b47c89
Public Version Date: August 17, 2023
Public Version Number: 5
DI Record Publish Date: September 30, 2019