AccessGUDID - DEVICE: SIRIUS (00880304543737)

GUDID

Device Identifier (DI) Information

Brand Name: SIRIUS
Version or Model: 31-149107
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 31-149107
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304543737
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 129278169 *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:	No
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?
36167	Orthopaedic broach	A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
KWL	Prosthesis, hip, hemi-, femoral, metal
PBI	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
MEH	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
OQG	Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
LZY	Prosthesis, hip, hemi-, femoral, metal ball
JDG	Prosthesis, hip, femoral component, cemented, metal
OQI	Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
OQH	Hip, semi-constrained, cemented, metal/polymer + additive, cemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130610	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
Device Size Text, specify: SIZE G

Device Record Status

Public Device Record Key: 5504411a-23c6-4068-9323-a1a305d5852a
Public Version Date: May 30, 2025
Public Version Number: 4
DI Record Publish Date: October 28, 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: 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: +1(800)348-9500
Email: customerservice@zimmerbiomet.com

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