FDA.reportPublic FDA data

Perfuse™ Decompression System

Primary DI
00887868263033
Brand
Perfuse™ Decompression System
Company
Biomet Biologics, LLC
Model
800-0542
Catalog number
800-0542
Published
2019-04-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141762000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141762000PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEMBiomet, Inc.2014-08-27FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868263033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868263033008878682630338878682630330887868263033

GMDN Terms#

Term, Definition table
TermDefinition
Bone trephineAn orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
802003074
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350023774307Calcibon401163000140116300012025-10-09
00880304640962Bilateral BMA Kit800-0710800-07102021-10-30
00887868284830Calcigen® S Bone Graft System3480103480102019-01-11
00887868284847Calcigen® S Bone Graft System3480123480122019-01-11
00887868284854Calcigen® S Bone Graft System3480143480142019-01-11
00880304400092Plasmax® Counterbalance800-0510800-05102019-06-11
00880304443112Plasmax® Plus Counterbalance800-0512800-05122019-06-11
00880304484757Biomet®800-0270800-02702019-06-11
00887868306730Biomet® Biologics800-0274800-02742019-06-11
00880304451759BMA Kit800-0705800-07052019-02-22
00880304460645GPS® III800-0744800-07442016-11-03
00880304460652GPS® III800-0745800-07452016-11-03
00880304508781BIOMET® BIOLOGICS800-0274800-02742016-11-03
00880304521513GPS®III Mini Platelet Concentration System800-0505A800-0505A2018-11-13
00880304640856Plasmax® Plasma Concentration Kit800-0516800-05162018-11-27
00880304640917BioCUE®800-0614800-06142016-11-03
00880304640924BioCUE®800-0615800-06152016-11-03
00880304641068GPS® III PLATELET CONCENTRATION SYSTEM800-1006A800-1006A2016-11-03
00880304680333PERFUSE DECOMPRESSION INSTRUMENTATION800-0546800-05462016-11-03
00880304681446Plasmax® Plus Plasma Concentration Kit800-0517800-05172018-11-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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