10807

GUDID 00816342023719

7mm Slotted Tendon Harvester

PARCUS MEDICAL LLC

Tendon stripper
Primary Device ID00816342023719
NIH Device Record Key6f64b23f-f6bc-4d5b-b854-a953091dc20a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number10807
Catalog Number10807
Company DUNS859961950
Company NamePARCUS MEDICAL LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816342023719 [Primary]

FDA Product Code

HRTStripper, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816342023719]

Moist Heat or Steam Sterilization


[00816342023719]

Moist Heat or Steam Sterilization


[00816342023719]

Moist Heat or Steam Sterilization


[00816342023719]

Moist Heat or Steam Sterilization


[00816342023719]

Moist Heat or Steam Sterilization


[00816342023719]

Moist Heat or Steam Sterilization


[00816342023719]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-16
Device Publish Date2021-08-06

Devices Manufactured by PARCUS MEDICAL LLC

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00816342025447 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
00816342025454 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
00816342025461 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
00816342025478 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm
00816342025485 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm
00816342025492 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm
00816342025508 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm

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