7 x 15mm CitreLock Xpress Implant Kit 70-812-0715

GUDID 00810027270344

Acuitive Technologies, Inc.

Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use
Primary Device ID00810027270344
NIH Device Record Key49be7304-e666-4a87-a6ad-4d8843139b58
Commercial Distribution StatusIn Commercial Distribution
Brand Name7 x 15mm CitreLock Xpress Implant Kit
Version Model Number70-812-0715
Catalog Number70-812-0715
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 Usetrue
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
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
GS100810027270344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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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