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
00888937033687ONETRACC1001502026-07-10
00888937033694ONETRACC1001652026-07-10
00888937033700ONETRACC1001702026-07-10
00888937033717ONETRACC1001802026-07-10
00888937033724ONETRACC1001902026-07-10
00888937033731ONETRAC LXC1002102026-07-10
00888937033748ONETRAC LXC1002202026-07-10
00888937033755ONETRAC LXC1002302026-07-10
00888937033762ONETRAC LXC1002402026-07-10
00888937033779ONETRAC LXC1002502026-07-10
00888937033786ONETRAC™ LXSC1002602026-07-10
00888937033793ONETRAC™ LXSC1002702026-07-10
00888937033809ONETRAC™ LXSC1002802026-07-10
00888937033816ONETRAC™ LXSC1002902026-07-10
00888937033823ONETRAC™ LXSC1102002026-07-10
00888937033830ONETRAC™ LXSC1102102026-07-10
00888937033847ONETRAC™ LXSC1102202026-07-10
00888937033854ONETRAC™ LXSC1103102026-07-10
00888937033861ONETRAC™ LXSC1103202026-07-10
00888937033663ONETRAC™C1001102026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091872ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-10
00810158211193PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00810158219861PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00888937033687ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033694ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033700ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033717ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033724ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033731ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033748ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033755ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033762ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033779ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033786ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10
00888937033793ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10
00888937033809ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10
00888937033816ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10
07640177823564Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823571Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823588Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823595Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823601Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823748Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823755Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823762Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823779Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823786Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823793Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823809Neo Medical RetractorsNeo Medical SAGAD2026-07-10
B382SD9044561000Surgical DirectSurgical Direct, Inc.GAD2026-07-10