AccessGUDID - DEVICE: Gel-One® Cross-linked Hyaluronate (00087541300912)

GUDID

Device Identifier (DI) Information

Brand Name: Gel-One® Cross-linked Hyaluronate
Version or Model: 00-1111-001-00
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00-1111-001-00
Company Name: SEIKAGAKU CORPORATION

Primary DI Number: 00087541300912
Issuing Agency: GS1
Commercial Distribution End Date: January 05, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 690584057 *Terms of Use

Device Description: Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics (e.g., acetaminophen). Gel-One is physician-administered, and is injected directly into the cavity of the knee joint. It is delivered via a single-use, pre-filled disposable glass syringe containing 3 mL of Gel-One.

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?
44757	Synovial fluid supplementation medium	A sterile viscous/elastic solution or gel (e.g., comprised of hyaluronic acids and their polymeric derivatives) intended to be injected into joints (particularly large, load-bearing joints such as the hip or knee) to help cushion the joint, especially in cases of endogenous synovial fluid reduced viscosity from degenerative disease.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MOZ	Acid, Hyaluronic, Intraarticular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P080020	012
P080020	013
P080020	014
P080020	015
P080020	016
P080020	017
P080020	018
P080020	019
P080020	020
P080020	021
P080020	022
P080020	023
P080020	024
P080020	025
P080020	027
P080020	028
P080020	029
P080020	030
P080020	031
P080020	032
P080020	033
P080020	035
P080020	036
P080020	037
P080020	038
P080020	039
P080020	040

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
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4aae65b2-5381-4f58-976e-3f5f1bf2aee8
Public Version Date: March 22, 2021
Public Version Number: 11
DI Record Publish Date: September 17, 2014