AccessGUDID - DEVICE: SYNOJOYNT (00357844181137)

GUDID

Device Identifier (DI) Information

Brand Name: SYNOJOYNT
Version or Model: 57844-181
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 57844-181
Company Name: TEVA PHARMACEUTICALS USA, INC.

Primary DI Number: 00357844181137
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 001627975 *Terms of Use

Device Description: prefilled syringe

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:	Yes
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 [?]
P170016	000

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
Handling Environment Temperature: between 36 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c659f2e0-66cc-4069-a22a-ee869cc6f828
Public Version Date: May 16, 2019
Public Version Number: 1
DI Record Publish Date: May 08, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30357844181138	30	00357844181137		In Commercial Distribution	Shipping Case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00357844181212 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: +1(888)838-2872
Email: TevaCS@tevapharm.com

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