AccessGUDID - DEVICE: HIP PRESERVATION SYSTEM (10845854018743)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 10845854018743
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 PORTAL DILATOR, LARGE, 6.0 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?
37086	Endoscope sheath, reusable	A component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic manual surgical instrument

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: 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
Device Size Text, specify: 6.0 MM

Device Record Status

Public Device Record Key: 5ce8e074-d33c-4ec5-9ff3-2c6986100f0e
Public Version Date: August 14, 2024
Public Version Number: 4
DI Record Publish Date: May 05, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: Yes
DM DI Number: 20845854018740
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(866)426-6633
Email: CustomerExperience@conmed.com

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