AccessGUDID - DEVICE: HIP PRESERVATION SYSTEM (10845854027257)

GUDID

Device Identifier (DI) Information

Brand Name: HIP PRESERVATION SYSTEM
Version or Model: HPS-SC67
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HPS-SC67
Company Name: Conmed Corporation

Primary DI Number: 10845854027257
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: HIP PRESERVATION SYSTEM LOW PROFILE SLOTTED CANNULA, 6.7 MM

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?
62458	Arthroscopic access cannula, reusable	A single-lumen, surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBH	ACCESSORIES,ARTHROSCOPIC

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 6.7 Millimeter

Device Record Status

Public Device Record Key: f5fb372b-c9d9-45b3-b3fd-ec9e49138cb7
Public Version Date: August 14, 2024
Public Version Number: 3
DI Record Publish Date: September 24, 2020