Citrelock ACL 10mm Femoral Reamer 40-103-3100

GUDID 00810027271372

Acuitive Technologies, Inc.

Cannulated surgical drill bit, reusable
Primary Device ID00810027271372
NIH Device Record Key1690804a-d90f-49cd-b0d1-91efc2e9920d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCitrelock ACL 10mm Femoral Reamer
Version Model Number40-103-3100
Catalog Number40-103-3100
Company DUNS074645634
Company NameAcuitive Technologies, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810027271372 [Primary]

FDA Product Code

HTOReamer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810027271372]

Moist Heat or Steam Sterilization


[00810027271372]

Moist Heat or Steam Sterilization


[00810027271372]

Moist Heat or Steam Sterilization


[00810027271372]

Moist Heat or Steam Sterilization


[00810027271372]

Moist Heat or Steam Sterilization


[00810027271372]

Moist Heat or Steam Sterilization


[00810027271372]

Moist Heat or Steam Sterilization


[00810027271372]

Moist Heat or Steam Sterilization


[00810027271372]

Moist Heat or Steam Sterilization


[00810027271372]

Moist Heat or Steam Sterilization


[00810027271372]

Moist Heat or Steam Sterilization


[00810027271372]

Moist Heat or Steam Sterilization


[00810027271372]

Moist Heat or Steam Sterilization


[00810027271372]

Moist Heat or Steam Sterilization


[00810027271372]

Moist Heat or Steam Sterilization


[00810027271372]

Moist Heat or Steam Sterilization


[00810027271372]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-03
Device Publish Date2023-06-23

Devices Manufactured by Acuitive Technologies, Inc.

00810027271594 - Citrelock ACL Tibial Drill Guide, Flat Hook2024-12-11
00810027271600 - Citrelock ACL 6mm Femoral Drill Guide, Straight Tip2024-12-11
00810027271617 - Citrelock ACL 7mm Femoral Drill Guide, Straight Tip2024-12-11
00810027271624 - Citrelock ACL 1.5mm K-Wire2024-12-11
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.