FDA.reportPublic FDA data

Zimmer Biomet™ X Series Power System

Primary DI
00889024521292
Brand
Zimmer Biomet™ X Series Power System
Company
Zimmer Surgical SA
Model
89-8522-440-90
Catalog number
89-8522-440-90
Published
2021-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEYMOTOR, SURGICAL INSTRUMENT, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024521292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024521292008890245212928890245212920889024521292

GMDN Terms#

Term, Definition table
TermDefinition
Sternum saw blade guideA protective device with a bulbous distal end used together with a sternal saw blade when cutting open the sternum (the breastbone) during cardiovascular surgery. The saw blade will operate within the confines of this device that protects the underlying organs from contact with the end of the reciprocating blade. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
481290781
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024687462Zimmer Biomet®1100462981100462982025-04-01
00889024355163Zimmer Biomet™89-8510-440-3089-8510-440-302022-06-10
00889024581746Zimmer Biomet™89-8521-470-4089-8521-470-402020-09-03
00889024355149Zimmer Biomet™89-8510-440-1089-8510-440-102016-05-16
00889024521117Zimmer Biomet™ X Series Power System8985204000089-8520-400-002020-09-03
00889024521124Zimmer Biomet™ X Series Power System8985204001089-8520-400-102020-09-03
00889024354593Zimmer® Universal Power System8985074000089-8507-400-002016-05-16
00889024354609Zimmer® Universal Power System8985074001089-8507-400-102016-05-16
00889024581760Zimmer Biomet™89-8521-470-8089-8521-470-802022-12-16
00887868572890Zimmer Biomet®89-8522-150-7089-8522-150-702023-09-28
00887868572906Zimmer Biomet®89-8522-270-7089-8522-270-702023-09-28
00887868572913Zimmer Biomet®89-8522-600-7089-8522-600-702023-09-28
00889024521100Zimmer Biomet™89-8521-470-7089-8521-470-702022-12-16
00889024490109Zimmer Biomet™89-8509-451-4689-8509-451-462022-06-10
00889024521339Zimmer Biomet™89-8522-451-4289-8522-451-422020-09-03
00889024521346Zimmer Biomet™89-8522-451-4389-8522-451-432020-09-03
00889024354951Zimmer Biomet™89-8509-451-4189-8509-451-412016-05-16
00889024421530Zimmer Biomet™89-8509-451-4289-8509-451-422016-05-16
00889024421547Zimmer Biomet™89-8509-451-4389-8509-451-432016-05-16
00889024581722Zimmer Biomet™89-8521-470-2089-8521-470-202020-09-03

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