FDA.reportPublic FDA data

Lone Star

Primary DI
00888937015355
Brand
Lone Star
Company
Coopersurgical, Inc.
Model
3302G
Device description
Lone Star Disposable Retractor Ring - 22.0 cm x 11.3 cm
Published
2022-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937015355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937015355008889370153558889370153550888937015355

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system mounting frame, single-use, sterileA sterile, noninvasive mounting device (e.g., a large ring, table-fixed bridging bar) designed as a component of a surgical retraction system, intended to be placed/fixed around a surgical incision site and upon which retraction system blades/components are mounted to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during surgery. It does not include the invasive retraction blades/components (i.e., is not the complete system). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter11.3Centimeter
Outer Diameter22Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937028508LifeGlobal® MediaH5TF-010MH5TF-010M2026-05-11
00888937028515LifeGlobal® MediaH5TF-050MH5TF-050M2026-05-11
00888937028522LifeGlobal® MediaH5TF-100MH5TF-100M2026-05-11
00888937028539LifeGlobal® MediaLGGF-050MLGGF-050M2026-05-11
00888937028546LifeGlobal® MediaLGGF-100MLGGF-100M2026-05-11
00888937028614LifeGlobal® MediaGCOL-100MGCOL-100M2026-05-11
00888937028621LifeGlobal® MediaGCOL-500MGCOL-500M2026-05-11
00888937028638LifeGlobal® MediaLGOL-100MLGOL-100M2026-05-11
00888937028645LifeGlobal® MediaLGOL-500MLGOL-500M2026-05-11
00888937028652LifeGlobal® MediaAMLO-100MAMLO-100M2026-05-11
00888937028669LifeGlobal® MediaLGPO-100MLGPO-100M2026-05-11
00888937028676LifeGlobal® MediaLGPO-500MLGPO-500M2026-05-11
00888937028683LifeGlobal® MediaAMPO-100MAMPO-100M2026-05-11
00888937028690LifeGlobal® MediaLGUA-100MLGUA-100M2026-05-11
00888937028706LifeGlobal® MediaLGUA-500MLGUA-500M2026-05-11
00888937028713LifeGlobal® MediaAMLG-100MAMLG-100M2026-05-11
00888937028935LifeGlobal® MediaH5TH-050MH5TH-050M2026-05-11
00888937028942LifeGlobal® MediaH5TH-100MH5TH-100M2026-05-11
00888937029017LifeGlobal® MediaLGGH-050MLGGH-050M2026-05-11
00888937029024LifeGlobal® MediaLGGH-100MLGGH-100M2026-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810118343124StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343131StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343148StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343155StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343162StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343179StieberAutomated Medical Products Corp.GAD2026-05-28
00841536147810ThompsonThompson Surgical Instruments, Inc.GAD2026-05-27
G453BH72800PEAK MEDICALPeak Medical Distribution Inc.GAD2026-03-30
07640332476321SCARLET AL-T INSTRUMENTATIONSpineArt SAGAD2025-11-10
07640375234681PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234698PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234704PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234711PERLA ® TL MISSpineArt SAGAD2025-11-10
08904332600681MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
08904332600698MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
08904332600704MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
08904332600711MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
G453TR251320PEAK MEDICALPeak Medical Distribution Inc.GAD2025-10-15
08800071700487Tiger ViewKims Med Co.,Ltd.GAD2025-10-15
08800071017240SignexOSTEONIC CO.,Ltd.GAD2025-06-24
08904332600582MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600599MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600605MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600612MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600629MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600476MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08904332600483MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08904332600490MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08800071700357Tiger ViewKims Med Co.,Ltd.GAD2025-02-10
08800071700371Tiger View Kims Med Co.,Ltd.GAD2025-02-10