FDA.reportPublic FDA data

Zimmer Biomet™

Primary DI
00889024355316
Brand
Zimmer Biomet™
Company
Zimmer Surgical SA
Model
89-8509-410-85
Catalog number
89-8509-410-85
Published
2016-05-16
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
HABSaw, Powered, And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HABSaw, Powered, And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024355316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024355316008890243553168890243553160889024355316

GMDN Terms#

Term, Definition table
TermDefinition
Drilling power tool attachment, basicA device 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 drilling function when an appropriate drill bit is inserted. It may include integral design features, e.g., have an angled head, be cannulated, have an attached Jacobs chuck, or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1(800)348-2759zimmer.consumerrelations@zimmer.com
+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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Primary DI, Brand, Company table
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