AccessGUDID - DEVICE: HTR-PEKK (00813298026443)

GUDID

Device Identifier (DI) Information

Brand Name: HTR-PEKK
Version or Model: PK619074-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OXFORD PERFORMANCE MATERIALS, INC.

Primary DI Number: 00813298026443
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962301359 *Terms of Use

Device Description: No description.

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?
58908	Custom-made cranial bone prosthesis	An implantable device intended to repair a defect of the cranium or mandible that is designed and constructed with specific characteristics (e.g., size, shape, material) as prescribed by a healthcare provider for a specified patient. It is typically manufactured from a three-dimensional (3-D) model based on computed tomography (CT) images and made of plastic [e.g., ultrahigh molecular weight polyethylene (UHMWPE), polyetheretherketone (PEEK)] and/or metal [e.g., titanium (Ti)]. The device may be used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease, or for cosmetic/aesthetic purposes.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GXN	Plate, Cranioplasty, Preformed, Non-Alterable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121818	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: da2ee0a0-544e-4373-813c-65d10cbcbf3b
Public Version Date: January 08, 2021
Public Version Number: 4
DI Record Publish Date: February 06, 2017

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

Customer Contact

[?]

Phone: 904-741-4400
Email: fxjax-orders@biomet.com

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