FDA.reportPublic FDA data

Klein Surgical

Primary DI
10850048763620
Brand
Klein Surgical
Company
Klein Surgical Systems, Inc.
Model
GI1085U
Catalog number
GI1085U
Device description
Universal Klein Vascular 30mm
Published
2023-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCILaryngoscope, Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCILaryngoscope, EndoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930496000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930496000GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPSBirtcher Medical Systems, Inc.1993-04-20GCI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850048763620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085004876362010850048763620

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical ligation clip applierA surgical device intended to be used in conjunction with a robotic surgical system to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding (i.e., haemostasis) during a robotic endoscopic (e.g., laparoscopic) procedure. It may also be used to apply small clamps (e.g., bulldog type) to tissues, however it is not intended to apply an aneurysm clip. The device is typically a metallic instrument with flat, curved ends to hold and deliver the clips (e.g., forceps-like) and a proximal housing intended to be connected directly to an arm of the robotic surgical system. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height10.6Millimeter
Length75Millimeter
Width8.6Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
210-280-4324info@kleinsurgical.com

Regulatory Flags#

DUNS number
072364974
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850048763644Klein SurgicalGI3000GI30002024-01-11
10850048763804Klein Surgical3021-033021-032023-08-31
30850048763808Klein Surgical3021-033021-032023-08-31
10850048763194Klein Surgical300-100-771300-100-7712023-07-17
10850048763200Klein Surgical300-100-772300-100-7722023-07-17
10850048763217Klein Surgical300-100-773300-100-7732023-07-17
10850048763224Klein Surgical300-100-774300-100-7742023-07-17
10850048763231Klein Surgical300-100-775300-100-7752023-07-17
10850048763248Klein Surgical300-100-776300-100-7762023-07-17
10850048763255Klein Surgical300-100-777300-100-7772023-07-17
10850048763262Klein Surgical300-100-778300-100-7782023-07-17
10850048763279Klein Surgical300-100-779300-100-7792023-07-17
10850048763286Klein Surgical300-100-789300-100-7892023-07-17
10850048763309Klein Surgical300-400-775300-400-7752023-07-17
10850048763354Klein Surgical300-410-775300-410-7752023-07-17
10850048763613Klein SurgicalGI1075UGI1075U2023-07-17
10850048763637Klein SurgicalGI1095UGI1095U2023-07-17
10850048763651Klein SurgicalGI9000GI90002023-07-17
00841019110027Klein3021-032016-07-10
20841019110021Klein3021-032016-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.GCI2026-04-30
G4533352505380PEAK MEDICALPeak Medical Distribution Inc.GCI2024-10-09
10850048763194Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763200Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763217Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763224Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763231Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763248Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763255Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763262Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763279Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763286Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763309Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763354Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763613Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763637Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10850048763651Klein SurgicalKlein Surgical Systems, Inc.GCI2023-07-17
10884523000948Endo Catch IICovidien LPGCI2016-09-24
10884523000955Endo Catch GoldCovidien LPGCI2016-09-24
20884523000945Endo Catch IICovidien LPGCI2016-09-24
20884523000952Endo Catch GoldCovidien LPGCI2016-09-24
30884521164820SurgiSleeveCovidien LPGCI2016-09-24
30884521164837SurgiSleeveCovidien LPGCI2016-09-24
20884521164816SurgiSleeveCovidien LPGCI2016-09-24