AccessGUDID - DEVICE: HIP PRESERVATION SYSTEM SIGNATURE SERIES (10845854029893)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 10845854029893
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: HIP PRESERVATION SYSTEM HIP ACCESS NEEDLE PACK, 17 G

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:	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?
44093	Arthroscopic surgical procedure kit, non-medicated, single-use	A collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 561cb62f-d5cf-4fd8-bf30-5d552ea81fa8
Public Version Date: August 14, 2024
Public Version Number: 2
DI Record Publish Date: October 14, 2021