AccessGUDID - DEVICE: SSP Remote Injection Port (M746RIPL0)

GUDID

Device Identifier (DI) Information

Brand Name: SSP Remote Injection Port
Version or Model: RIP-L
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RIP-L
Company Name: SPECIALTY SURGICAL PRODUCTS INC

Primary DI Number: M746RIPL0
Issuing Agency: HIBCC
Commercial Distribution End Date: November 11, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 002112626 *Terms of Use

Device Description: Remote Injection Port with Tubing, Large For Use with SSP Remote Injection Port Tissue Expanders

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?
59036	Tissue expander injection port	A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids (e.g., saline) typically over multiple expansion sessions. It consists of an auto-sealing port for needle puncture and a tube connector for attachment to the tissue expander. It is available in a variety of designs. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LCJ	Expander, Skin, Inflatable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2652f929-3dcf-4251-bef1-9a4b4f2c4db7
Public Version Date: September 21, 2023
Public Version Number: 4
DI Record Publish Date: September 15, 2015