AccessGUDID - DEVICE: Agili-C (07290019087182)

GUDID

Device Identifier (DI) Information

Brand Name: Agili-C
Version or Model: CHP0755
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CARTIHEAL (2009) LTD

Primary DI Number: 07290019087182
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533214388 *Terms of Use

Device Description: 5X Agili-C D7.5 Implant

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
58054	Osteochondral matrix implant	A sterile bioabsorbable device designed to be implanted to fill osteochondral defects. It is a porous and multilayered device, one layer of synthetic bone substitute material (e.g. ceramics such as tricalcium phosphate or hydroxyapatite) combined with a biological material (e.g., bovine collagen) intended to provide an osteoconductive bone tissue scaffold, and a second layer of predominantly biological material (e.g., bovine collagen) intended to provide a matrix structure that promotes the ingrowth of autologous cells for cartilage regeneration. Instruments to prepare the defect site and insert the implant may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QRU	Implant, Resorbable, For Articular Osteochondral Repair

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P210034	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 21b718e7-dab1-4417-b8c3-2b2c39e04d03
Public Version Date: June 08, 2023
Public Version Number: 1
DI Record Publish Date: May 31, 2023

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: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: +97298810400
Email: info@cartiheal.com

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