AccuZone (Assisted FreeHand Guide) 323.100

GUDID 00889024406469

ZIMMER KNEE CREATIONS, INC.

Surgical drill guide, single-use
Primary Device ID00889024406469
NIH Device Record Keybfef7acb-f71e-4d85-8276-7aa1ad59d1a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccuZone (Assisted FreeHand Guide)
Version Model Number323.100
Catalog Number323.100
Company DUNS078836317
Company NameZIMMER KNEE CREATIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone484-887-8902
EmailKC.Customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024406469 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-08-09
Device Publish Date2016-05-19

Devices Manufactured by ZIMMER KNEE CREATIONS, INC.

00889024594043 - SCP® PF Knee Kit, 4PK2020-07-31
00889024594050 - SCP® PF Knee Kit, 4PK2020-07-31
00889024594067 - SCP® PF Knee Kit, 4PK2020-07-31
00889024594074 - SCP® PF Knee Kit, 4PK2020-07-31
00889024594081 - SCP® PF Foot & Ankle Kit, 4PK2020-07-31
00889024594098 - SCP® PF Foot & Ankle Kit, 4PK2020-07-31
00889024594104 - SCP® PF Foot & Ankle Kit, 4PK2020-07-31
00889024594111 - SCP® PF Hip Kit, 4 Pack2020-07-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.