Klein Surgical 300-410-775

GUDID 10850048763354

Klein Bulldog Applier 10mm Det

Klein Surgical Systems, Inc.

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Primary Device ID10850048763354
NIH Device Record Keyd072c4e6-388b-4184-afd0-f0aea5d3a676
Commercial Distribution StatusIn Commercial Distribution
Brand NameKlein Surgical
Version Model Number300-410-775
Catalog Number300-410-775
Company DUNS072364974
Company NameKlein Surgical Systems, 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 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

Phone210-280-4324
Emailinfo@kleinsurgical.com
Phone210-280-4324
Emailinfo@kleinsurgical.com
Phone210-280-4324
Emailinfo@kleinsurgical.com
Phone210-280-4324
Emailinfo@kleinsurgical.com
Phone210-280-4324
Emailinfo@kleinsurgical.com
Phone210-280-4324
Emailinfo@kleinsurgical.com
Phone210-280-4324
Emailinfo@kleinsurgical.com
Phone210-280-4324
Emailinfo@kleinsurgical.com
Phone210-280-4324
Emailinfo@kleinsurgical.com
Phone210-280-4324
Emailinfo@kleinsurgical.com
Phone210-280-4324
Emailinfo@kleinsurgical.com
Phone210-280-4324
Emailinfo@kleinsurgical.com
Phone210-280-4324
Emailinfo@kleinsurgical.com
Phone210-280-4324
Emailinfo@kleinsurgical.com
Phone210-280-4324
Emailinfo@kleinsurgical.com
Phone210-280-4324
Emailinfo@kleinsurgical.com

Device Dimensions

Length345 Millimeter
Circumference10 Millimeter
Length345 Millimeter
Circumference10 Millimeter
Length345 Millimeter
Circumference10 Millimeter
Length345 Millimeter
Circumference10 Millimeter
Length345 Millimeter
Circumference10 Millimeter
Length345 Millimeter
Circumference10 Millimeter
Length345 Millimeter
Circumference10 Millimeter
Length345 Millimeter
Circumference10 Millimeter
Length345 Millimeter
Circumference10 Millimeter
Length345 Millimeter
Circumference10 Millimeter
Length345 Millimeter
Circumference10 Millimeter
Length345 Millimeter
Circumference10 Millimeter
Length345 Millimeter
Circumference10 Millimeter
Length345 Millimeter
Circumference10 Millimeter
Length345 Millimeter
Circumference10 Millimeter
Length345 Millimeter
Circumference10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110850048763354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCILaryngoscope, Endoscope

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10850048763354]

Moist Heat or Steam Sterilization


[10850048763354]

Moist Heat or Steam Sterilization


[10850048763354]

Moist Heat or Steam Sterilization


[10850048763354]

Moist Heat or Steam Sterilization


[10850048763354]

Moist Heat or Steam Sterilization


[10850048763354]

Moist Heat or Steam Sterilization


[10850048763354]

Moist Heat or Steam Sterilization


[10850048763354]

Moist Heat or Steam Sterilization


[10850048763354]

Moist Heat or Steam Sterilization


[10850048763354]

Moist Heat or Steam Sterilization


[10850048763354]

Moist Heat or Steam Sterilization


[10850048763354]

Moist Heat or Steam Sterilization


[10850048763354]

Moist Heat or Steam Sterilization


[10850048763354]

Moist Heat or Steam Sterilization


[10850048763354]

Moist Heat or Steam Sterilization


[10850048763354]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-25
Device Publish Date2023-07-17

On-Brand Devices [Klein Surgical]

10850048763651Klein Universal Robotic Bulldog
10850048763637Universal Klein Vascular 25mm
10850048763620Universal Klein Vascular 30mm
10850048763613Ewing/Klein Chol Clamp
10850048763354Klein Bulldog Applier 10mm Det
10850048763309Klein Bulldog Applier 10mm
10850048763286Endoscopic Bulldog Clamp 60mm
10850048763279Klein Bulldog Clamp 60mm Curved
10850048763262Klein Bulldog Clamp 45mm Curved
10850048763255Klein Bulldog Clamp 25mm Curved
10850048763248Klein Bulldog Clamp 17mm Curved
10850048763231Klein Bulldog Clamp 35mm Straight
10850048763224Klein Bulldog Clamp 25mm Straight
10850048763217Klein Bulldog Clamp 17mm Straight
10850048763200Klein Bulldog Clamp 60mm Straight
10850048763194Klein Bulldog Clamp 45mm Straight
30850048763808Disposable Monopolar Endoscopic Cord 10 ft. (3.0m)
10850048763644Klein Sterilization Tray

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