AccessGUDID - DEVICE: BIOSTOP (10603295174561)

GUDID

Device Identifier (DI) Information

Brand Name: BIOSTOP
Version or Model: 5463-12-000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 546312000
Company Name: DEPUY ORTHOPAEDICS, INC.

Primary DI Number: 10603295174561
Issuing Agency: GS1
Commercial Distribution End Date: January 27, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 080506581 *Terms of Use

Device Description: BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 12

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?
38071	Polymer orthopaedic cement restrictor, bioabsorbable	A sterile, implantable device that is chemically degraded and absorbed via natural body processes designed to be inserted into the medullary canal of a bone (e.g., femur, tibia, or humerus) during orthopaedic surgery to prevent cement progression in the diaphysis and therefore facilitate cement pressurization during the introduction of an implant. It is made of bioabsorbable synthetic polymer materials and is available in a variety of designs, e.g., straight or tapered, hollow with a fenestrated surface, and it may have a toothed surface to prevent its migration from the desired location. It may incorporate a metal orientation marker for radiographs and is not intended for spinal indication.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LZN	CEMENT OBTURATOR
JDK	Prosthesis, hip, cement restrictor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d8e22e77-b62a-44c0-b759-2b58e54592ce
Public Version Date: November 26, 2024
Public Version Number: 7
DI Record Publish Date: September 24, 2015