AccessGUDID - DEVICE: Hintermann Series H3 (B095300607)

GUDID

Device Identifier (DI) Information

Brand Name: Hintermann Series H3
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 300607
Company Name: Dt Medtech, LLC

Primary DI Number: B095300607
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080101891 *Terms of Use

Device Description: H3 PE INLAY SIZE 6- 7mm

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?
48180	Ankle prosthesis bearing	A sterile implantable device made of polyethylene (PE) designed to articulate the tibial and talar components of a total ankle prosthesis.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NTG	Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160036	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: 1f22d702-db0b-4412-a819-268ade576883
Public Version Date: February 27, 2024
Public Version Number: 4
DI Record Publish Date: August 19, 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
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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 999-999-9999
Email: quality@dtmedtech.com

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