FDA.reportPublic FDA data

Echo Bi-Met

Primary DI
00889024518070
Brand
Echo Bi-Met
Company
Zimmer, Inc.
Model
SSI004625
Catalog number
SSI004625
Published
2018-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFABlade, Saw, General & Plastic Surgery, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024518070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024518070008890245180708890245180700889024518070

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument designed to resect (cut out part of the bone) and precisely shape a specific area of bone for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). It is commonly called a mill or a reamer and is typically designed as either a preshaped or a solid cylindrical body with an end or circumferential cutting edge. It is attached to a shaft for manual or powered rotation and may be steered over a guide or spigot that has been inserted into the site to control the cutting action. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1 (800) 343-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024081024XtraFix® Large External Fixation System00-5207-024-3000-5207-024-302016-08-09
00889024081055XtraFix® Large External Fixation System00-5207-032-3000-5207-032-302016-07-27
00889024081062XtraFix® Large External Fixation System00-5207-040-1000-5207-040-102016-07-28
00889024081079XtraFix® Large External Fixation System00-5207-040-7000-5207-040-702016-07-28
00889024081086XtraFix® Large External Fixation System00-5207-045-1000-5207-045-102016-07-28
00889024081093XtraFix® Large External Fixation System00-5210-009-0100-5210-009-012016-09-28
00889024081109XtraFix® Large External Fixation System00-5210-009-0200-5210-009-022016-09-28
00889024081147XtraFix® Large External Fixation System00-5210-019-0100-5210-019-012016-09-28
00889024081154XtraFix® Large External Fixation System00-5210-029-0100-5210-029-012016-09-28
00889024081178XtraFix® Large External Fixation System00-5210-040-0000-5210-040-002016-09-28
00889024081185XtraFix® Large External Fixation System00-5210-040-0100-5210-040-012016-09-28
00889024081192XtraFix® Large External Fixation System00-5210-040-0200-5210-040-022016-09-28
00889024081208XtraFix® Large External Fixation System00-5210-040-0300-5210-040-032016-09-28
00889024081215XtraFix® Large External Fixation System00-5210-040-0400-5210-040-042016-09-28
00889024081239XtraFix® Large External Fixation System00-5210-040-0600-5210-040-062016-09-28
00889024081253XtraFix® Large External Fixation System00-5210-050-0100-5210-050-012016-09-28
00889024081260XtraFix® Large External Fixation System00-5210-050-0200-5210-050-022016-09-28
00889024081277XtraFix® Large External Fixation System00-5210-050-0300-5210-050-032016-09-28
00889024081284XtraFix® Large External Fixation System00-5210-050-0400-5210-050-042016-09-28
00889024081307XtraFix® Large External Fixation System00-5210-050-0600-5210-050-062016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800053401531SharkCutTechcord co.,LtdGFA2024-04-16
08800053401548SharkCutTechcord co.,LtdGFA2024-04-16
08800053401586SharkCutTechcord co.,LtdGFA2024-04-16
08800053401593SharkCutTechcord co.,LtdGFA2024-04-16
08800053401616SharkCutTechcord co.,LtdGFA2024-04-16
08800053401623SharkCutTechcord co.,LtdGFA2024-04-16
08800053401647SharkCutTechcord co.,LtdGFA2024-04-16
08800053401654SharkCutTechcord co.,LtdGFA2024-04-16
08800053401678SharkCutTechcord co.,LtdGFA2024-04-16
08800053401692SharkCutTechcord co.,LtdGFA2024-04-16
08800053401142SharkCutTechcord co.,LtdGFA2024-04-15
08800053401159SharkCutTechcord co.,LtdGFA2024-04-15
08800053401166SharkCutTechcord co.,LtdGFA2024-04-15
08800053401173SharkCutTechcord co.,LtdGFA2024-04-15
08800053401180SharkCutTechcord co.,LtdGFA2024-04-15
08800053401197SharkCutTechcord co.,LtdGFA2024-04-15
08800053401203SharkCutTechcord co.,LtdGFA2024-04-15
08800053401210SharkCutTechcord co.,LtdGFA2024-04-15
08800053401227SharkCutTechcord co.,LtdGFA2024-04-15
08800053401234SharkCutTechcord co.,LtdGFA2024-04-15
08800053401241SharkCutTechcord co.,LtdGFA2024-04-15
08800053401258SharkCutTechcord co.,LtdGFA2024-04-15
08800053401289SharkCutTechcord co.,LtdGFA2024-04-15
08800053401296SharkCutTechcord co.,LtdGFA2024-04-15
08800053401302SharkCutTechcord co.,LtdGFA2024-04-15
08800053401319SharkCutTechcord co.,LtdGFA2024-04-15
08800053401326SharkCutTechcord co.,LtdGFA2024-04-15
08800053401333SharkCutTechcord co.,LtdGFA2024-04-15
08800053401340SharkCutTechcord co.,LtdGFA2024-04-15
08800053401357SharkCutTechcord co.,LtdGFA2024-04-15