CitreLock Tendon Fixation Lid 40-999-0003

GUDID 00810027270160

Acuitive Technologies, Inc.

Instrument tray, reusable

Primary Device ID	00810027270160
NIH Device Record Key	60b4e21d-1921-4549-8ff3-39f094c6ba2a
Commercial Distribution Status	In Commercial Distribution
Brand Name	CitreLock Tendon Fixation Lid
Version Model Number	40-999-0003
Catalog Number	40-999-0003
Company DUNS	074645634
Company Name	Acuitive Technologies, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx
Phone	201-661-2680
Email	xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810027270160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K200725

FDA Product Code

FSM	Tray, Surgical, Instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

[00810027270160]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-03-02
Device Publish Date	2021-02-22

Devices Manufactured by Acuitive Technologies, Inc.

00810027271594 - Citrelock ACL Tibial Drill Guide, Flat Hook	2024-12-11
00810027271600 - Citrelock ACL 6mm Femoral Drill Guide, Straight Tip	2024-12-11
00810027271617 - Citrelock ACL 7mm Femoral Drill Guide, Straight Tip	2024-12-11
00810027271624 - Citrelock ACL 1.5mm K-Wire	2024-12-11
00810027271471 - Citrelock ACL 1.1mm K-Wire	2024-03-07
00810027270436 - Citrefix 2.9mm Inserter	2023-07-03
00810027270443 - Citrefix 3.5mm Inserter	2023-07-03
00810027270450 - Citrefix 4.5mm Inserter	2023-07-03

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