Citrelock ACL 8mm Femoral Reamer 40-103-3080

GUDID 00810027271334

Acuitive Technologies, Inc.

Cannulated surgical drill bit, reusable
Primary Device ID00810027271334
NIH Device Record Keyee144d3b-6f0a-4872-b9d5-f6d12da088ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameCitrelock ACL 8mm Femoral Reamer
Version Model Number40-103-3080
Catalog Number40-103-3080
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
GS100810027271334 [Primary]

FDA Product Code

HTOReamer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810027271334]

Moist Heat or Steam Sterilization


[00810027271334]

Moist Heat or Steam Sterilization


[00810027271334]

Moist Heat or Steam Sterilization


[00810027271334]

Moist Heat or Steam Sterilization


[00810027271334]

Moist Heat or Steam Sterilization


[00810027271334]

Moist Heat or Steam Sterilization


[00810027271334]

Moist Heat or Steam Sterilization


[00810027271334]

Moist Heat or Steam Sterilization


[00810027271334]

Moist Heat or Steam Sterilization


[00810027271334]

Moist Heat or Steam Sterilization


[00810027271334]

Moist Heat or Steam Sterilization


[00810027271334]

Moist Heat or Steam Sterilization


[00810027271334]

Moist Heat or Steam Sterilization


[00810027271334]

Moist Heat or Steam Sterilization


[00810027271334]

Moist Heat or Steam Sterilization


[00810027271334]

Moist Heat or Steam Sterilization


[00810027271334]

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

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