AccessGUDID - DEVICE: N/A (00841036132323)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: SP-1915
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SP-1915
Company Name: BIOMET MICROFIXATION, INC

Primary DI Number: 00841036132323
Issuing Agency: GS1
Commercial Distribution End Date: July 27, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 046189866 *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?
35651	Cranioplasty sheet	A flat piece of implantable metal (typically tantalum) designed to repair small cranial bone defects (i.e., cranioplasty). It is usually perforated and can be shaped to a desired contour using a mallet and a wood block and cut with shears to an appropriate dimension, intraoperatively. Prefabricated metallic plates, which may be manufactured from metallic sheets, are frequently used to repair larger cranial bone defects.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JEY	PLATE, BONE
GWO	Plate, cranioplasty, preformed, alterable
HBW	FASTENER, PLATE, CRANIOPLASTY
GXR	COVER, BURR HOLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121589	000
K121624	000
K953385	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: 3e74f377-e163-4a92-bf3d-8afeacda5d84
Public Version Date: May 30, 2025
Public Version Number: 5
DI Record Publish Date: October 11, 2015

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(904)741-4400
Email: FXJAX-ORDERS@ZIMMERBIOMET.COM

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