Tensor Surgical VersaTip Suture Shuttle 4010

GUDID 00850019153187

Device used for capturing suture and making repairs

TENSOR SURGICAL, INC.

General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable
Primary Device ID00850019153187
NIH Device Record Key7151e909-2b12-4eab-8c95-71309006533a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTensor Surgical VersaTip Suture Shuttle
Version Model Number4010
Catalog Number4010
Company DUNS051885419
Company NameTENSOR SURGICAL, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850019153187 [Primary]
GS100850019153187 [Primary]
GS100850019153187 [Primary]
GS100850019153187 [Primary]
GS100850019153187 [Primary]
GS100850019153187 [Primary]
GS100850019153187 [Primary]
GS100850019153187 [Primary]
GS100850019153187 [Primary]
GS100850019153187 [Primary]
GS100850019153187 [Primary]
GS100850019153187 [Primary]
GS100850019153187 [Primary]
GS100850019153187 [Primary]
GS100850019153187 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850019153187]

Moist Heat or Steam Sterilization


[00850019153187]

Moist Heat or Steam Sterilization


[00850019153187]

Moist Heat or Steam Sterilization


[00850019153187]

Moist Heat or Steam Sterilization


[00850019153187]

Moist Heat or Steam Sterilization


[00850019153187]

Moist Heat or Steam Sterilization


[00850019153187]

Moist Heat or Steam Sterilization


[00850019153187]

Moist Heat or Steam Sterilization


[00850019153187]

Moist Heat or Steam Sterilization


[00850019153187]

Moist Heat or Steam Sterilization


[00850019153187]

Moist Heat or Steam Sterilization


[00850019153187]

Moist Heat or Steam Sterilization


[00850019153187]

Moist Heat or Steam Sterilization


[00850019153187]

Moist Heat or Steam Sterilization


[00850019153187]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

Devices Manufactured by TENSOR SURGICAL, INC.

00850019153187 - Tensor Surgical VersaTip Suture Shuttle2020-06-23Device used for capturing suture and making repairs
00850019153187 - Tensor Surgical VersaTip Suture Shuttle2020-06-23 Device used for capturing suture and making repairs
00850019153002 - Tensor Surgical2020-06-17 Reusable devices used as a kit to shuttle suture through bone

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