AccessGUDID - DEVICE: Agili-C (07290019087021)

GUDID

Device Identifier (DI) Information

Brand Name: Agili-C
Version or Model: CH-125
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CARTIHEAL (2009) LTD

Primary DI Number: 07290019087021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533214388 *Terms of Use

Device Description: Agili-C Implant Diameter 12.5mm, Length 10mm

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: ee60cd6f-a6e4-402d-99b6-c42371424d79
Public Version Date: October 12, 2022
Public Version Number: 1
DI Record Publish Date: October 04, 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: 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

[?]

No Customer Contact currently defined

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