AccessGUDID - DEVICE: restor3d Total Talus Replacement (00840097509891)

GUDID

Device Identifier (DI) Information

Brand Name: restor3d Total Talus Replacement
Version or Model: 6102-600
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Restor3d, Inc.

Primary DI Number: 00840097509891
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080819836 *Terms of Use

Device Description: Impactor, Flat

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?
66297	Custom-made hand/foot bone prosthesis	An implantable device designed and created for a specific patient to replace the whole or part of a bone in the hand or foot, including the wrist or ankle (e.g., carpal, metacarpal, tarsal or metatarsal bones), typically to treat avascular necrosis or other osteolytic conditions. It is made of metal [e.g., titanium (Ti) alloy]. Devices intended to assist implantation (e.g., trial prosthesis, surgical guide) may be included with the prosthesis.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QNN	Prosthesis, Total Talus Replacement, Metal
QYQ	Prosthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H230003	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 824dd059-c91f-41e1-bfc3-1531e10af05b
Public Version Date: March 25, 2024
Public Version Number: 1
DI Record Publish Date: March 15, 2024

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: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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