FDA.reportPublic FDA data

Zimmer Biomet®

Primary DI
00887868572913
Brand
Zimmer Biomet®
Company
Zimmer Surgical SA
Model
89-8522-600-70
Catalog number
89-8522-600-70
Published
2023-09-28
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
00887868572913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868572913008878685729138878685729130887868572913

GMDN Terms#

Term, Definition table
TermDefinition
Reaming power tool attachmentA small component of a powered reaming assembly intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a reaming function when an appropriate reamer endpiece (not included) is inserted. This is a reusable device.

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
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
00889024581739Zimmer Biomet™89-8521-470-3089-8521-470-302020-09-03

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