Compress Device

Basic Information

• Brand Name: Compress Device
• Primary DI: 00880304260641
• Version / Model: 178539
• Catalog Number: 178539
• Company Name: Biomet Orthopedics, LLC
• Labeler DUNS: 129278169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 4
• Public Version Date: 2020-11-03
• Public Version Status: Update
• Public Device Record Key: 3f2ecaf5-5aa0-4930-88d1-bef164fe60dd

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	Orthopedic	888.3350	2
MEH	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate	Orthopedic	888.3353	2
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	Orthopedic	888.3390	2
KRO	PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER	Orthopedic	888.3510	2
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	Orthopedic	888.3353	2
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED	Orthopedic	888.3358	2
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer	Orthopedic	888.3310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33746	Humeral centering sleeve	A sterile implantable device designed to fix a humeral stem prosthesis in the middle of the humeral canal. It is a metal cylinder [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] that fits over the distal end of the stem and is implanted into the humeral canal of the patient.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00880304260641	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K031804	000
K043547	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			17MM Ø