FDA.reportPublic FDA data

Klein Surgical

Primary DI
10850048763613
Brand
Klein Surgical
Company
Klein Surgical Systems, Inc.
Model
GI1075U
Catalog number
GI1075U
Device description
Ewing/Klein Chol Clamp
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
10850048763613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085004876361310850048763613

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic tissue manipulation forceps/working-channelA rigid, hand-held manual surgical instrument designed to be introduced through a laparoscope/laparoscopic port for: 1) atraumatic grasping/clamping of soft tissues (e.g., gallbladder); and 2) access adjacent to the site of clamping (e.g., during laparoscopic cholangiography). It is a hand-held device with proximal handles, a rigid long slender shaft with a built-in working-channel, and distal grasping blades. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Millimeter

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
10850048763620Klein SurgicalGI1085UGI1085U2023-07-17
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
10850048763620Klein 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