CitreLock Sizing Guide 40-101-0006

GUDID 00810027270016

Acuitive Technologies, Inc.

Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable
Primary Device ID00810027270016
NIH Device Record Keyaf0a35fb-2e4f-4b60-927f-3d8981c22f21
Commercial Distribution StatusIn Commercial Distribution
Brand NameCitreLock Sizing Guide
Version Model Number40-101-0006
Catalog Number40-101-0006
Company DUNS074645634
Company NameAcuitive Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone201-661-2680
Emailxxx@xx.xx
Phone201-661-2680
Emailxxx@xx.xx
Phone201-661-2680
Emailxxx@xx.xx
Phone201-661-2680
Emailxxx@xx.xx
Phone201-661-2680
Emailxxx@xx.xx
Phone201-661-2680
Emailxxx@xx.xx
Phone201-661-2680
Emailxxx@xx.xx
Phone201-661-2680
Emailxxx@xx.xx
Phone201-661-2680
Emailxxx@xx.xx
Phone201-661-2680
Emailxxx@xx.xx
Phone201-661-2680
Emailxxx@xx.xx
Phone201-661-2680
Emailxxx@xx.xx
Phone201-661-2680
Emailxxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100810027270016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810027270016]

Moist Heat or Steam Sterilization


[00810027270016]

Moist Heat or Steam Sterilization


[00810027270016]

Moist Heat or Steam Sterilization


[00810027270016]

Moist Heat or Steam Sterilization


[00810027270016]

Moist Heat or Steam Sterilization


[00810027270016]

Moist Heat or Steam Sterilization


[00810027270016]

Moist Heat or Steam Sterilization


[00810027270016]

Moist Heat or Steam Sterilization


[00810027270016]

Moist Heat or Steam Sterilization


[00810027270016]

Moist Heat or Steam Sterilization


[00810027270016]

Moist Heat or Steam Sterilization


[00810027270016]

Moist Heat or Steam Sterilization


[00810027270016]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-02
Device Publish Date2020-11-24

Devices Manufactured by Acuitive Technologies, Inc.

00810027271471 - Citrelock ACL 1.1mm K-Wire2024-03-07
00810027270436 - Citrefix 2.9mm Inserter2023-07-03
00810027270443 - Citrefix 3.5mm Inserter2023-07-03
00810027270450 - Citrefix 4.5mm Inserter2023-07-03
00810027270467 - Citrefix 5.5mm Inserter2023-07-03
00810027270474 - Citrefix 2.9mm Drill2023-07-03
00810027270481 - Citrefix 3.5mm Drill2023-07-03
00810027270498 - Citrefix 4.5mm Drill2023-07-03

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