GlenoTech GLE9000000

GUDID 03760304681295

Complete instrumentation set composed of reusable surgical instruments intended to be used for the surgical treatment of anterior shoulder instability.

S.B.M

Arthroscopic surgical procedure kit, non-medicated, reusable
Primary Device ID03760304681295
NIH Device Record Keybb5c7938-20e5-4e91-904c-911eb0006828
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlenoTech
Version Model NumberGlenoTech complete instrumentation set
Catalog NumberGLE9000000
Company DUNS772462123
Company NameS.B.M
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103760304681295 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760304681295]

Moist Heat or Steam Sterilization


[03760304681295]

Moist Heat or Steam Sterilization


[03760304681295]

Moist Heat or Steam Sterilization


[03760304681295]

Moist Heat or Steam Sterilization


[03760304681295]

Moist Heat or Steam Sterilization


[03760304681295]

Moist Heat or Steam Sterilization


[03760304681295]

Moist Heat or Steam Sterilization


[03760304681295]

Moist Heat or Steam Sterilization


[03760304681295]

Moist Heat or Steam Sterilization


[03760304681295]

Moist Heat or Steam Sterilization


[03760304681295]

Moist Heat or Steam Sterilization


[03760304681295]

Moist Heat or Steam Sterilization


[03760304681295]

Moist Heat or Steam Sterilization


[03760304681295]

Moist Heat or Steam Sterilization


[03760304681295]

Moist Heat or Steam Sterilization


[03760304681295]

Moist Heat or Steam Sterilization


[03760304681295]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-20
Device Publish Date2024-06-12

On-Brand Devices [GlenoTech]

03760304681295Complete instrumentation set composed of reusable surgical instruments intended to be used for t
03760304681059GlenoTech® diamter 5 mm cannulated drill bit

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