FDA.reportPublic FDA data

Klein Surgical

Primary DI
10850048763644
Brand
Klein Surgical
Company
Klein Surgical Systems, Inc.
Model
GI3000
Catalog number
GI3000
Device description
Klein Sterilization Tray
Published
2024-01-11
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
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850048763644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085004876364410850048763644

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height20.32Millimeter
Length190.5Millimeter
Width101.6Millimeter

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
00857915007750Endo ECTR TrayA.M. SURGICAL, INC.FSM2026-06-04
10705037042999STERRAD™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FSM2026-06-03
07613327605716PANGEAStryker GmbHFSM2026-06-02
07613327623260MakoMAKO SURGICAL CORP.FSM2026-05-29
08435389830207STOP & GUIDE® BOXBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
08435389830962DRILL HOLDER FOR EXTRA SHORT DRILLSBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
07630055307736ACE Acetabular Reamer Tray - Instrument TrayIncipio Devices SAFSM2026-04-30
07613327652765TPXSTRYKER CORPORATIONFSM2026-03-25
07613327631852RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631869RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631876RPSSTRYKER CORPORATIONFSM2025-10-01
07613327681741N/ASTRYKER CORPORATIONFSM2025-09-03
ESAM23080001STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080161STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6550401STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
07630894802683APTUSMedartis AGFSM2023-02-24
07630894802973APTUSMedartis AGFSM2023-02-24
07630894802980APTUSMedartis AGFSM2023-02-24
07630894802997APTUSMedartis AGFSM2023-02-24
07630894803208APTUSMedartis AGFSM2023-02-24
07630894803215APTUSMedartis AGFSM2023-02-24
07630894803222APTUSMedartis AGFSM2023-02-24
07630894803246APTUSMedartis AGFSM2023-02-24
07630894803260APTUSMedartis AGFSM2023-02-24
07630894803307APTUSMedartis AGFSM2023-02-24
07630894803314APTUSMedartis AGFSM2023-02-24
07630894803321APTUSMedartis AGFSM2023-02-24