AccessGUDID - DEVICE: HA TOTAL PROSTHESIS (00844505000079)

GUDID

Device Identifier (DI) Information

Brand Name: HA TOTAL PROSTHESIS
Version or Model: 106
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Grace Medical, Inc.

Primary DI Number: 00844505000079
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 030849173 *Terms of Use

Device Description: HA TOTAL PROSTHESIS 4MM OFFSET HEAD 0.8MM DIA. X 4MM LENGTH

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?
35674	Ossicular prosthesis, total	A sterile device intended to be implanted for the total functional reconstruction of the ossicular chain (mallues, incus, and stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of polymers.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
ETA	REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963752	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: fba5658f-1c49-469b-802c-dfba20213978
Public Version Date: July 27, 2020
Public Version Number: 4
DI Record Publish Date: February 18, 2016

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: Yes
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(866)472-2363
Email: info@gracemedical.com

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