FDA.reportPublic FDA data

Lone Star

Primary DI
00888937015515
Brand
Lone Star
Company
Coopersurgical, Inc.
Model
3316-1G
Device description
5 mm Elastic Stays, Blunt
Published
2020-09-25
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
20888937015519PackageGS150In Commercial Distribution
00888937015515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893701551920888937015519
00888937015515008889370155158889370155150888937015515

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system mounting frame, single-useA 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.

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
00888937027327ER-SpecC0203002026-08-05
00888937027334ER-SpecC0203102026-08-05
00888937027341ER-SpecC0203202026-08-05
00888937027358HER-SpecC0206002026-08-05
00888937027365HER-SpecC0206102026-08-05
00888937027372HER-SpecC0206202026-08-05
00888937027389OfficeSPECC0200012026-08-06
00888937027396HER-SpecC0205002026-08-06
00888937027402HER-SpecC0205102026-08-06
00888937027419HER-SpecC0205202026-08-06
00888937027426ER-SPECC020100-12026-08-06
00888937027433ER-SPECC020110-12026-08-06
00888937027440ER-SpecC020120-12026-08-06
00888937027457ER-SpecC020130-12026-08-06
00888937027464ER-SpecC020140-12026-08-06
00888937027594AnoSPECC0601002026-08-05
00888937027600AnoSPECC0601102026-08-05
00888937027617AnoSPECC0601202026-08-05
00888937032833LifeGlobal® Coda®Incubator UnitGCIU-010-M2026-08-03
00888937032840LifeGlobal® Coda®Filter for Incubator UnitGCIF-001-M2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432287MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432294MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432393MillenniumAvalign Technologies, Inc.GAD2026-09-24
00724995266912Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266943Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266950Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266967Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266974Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266981Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266998Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267001Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267025Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267032Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267537Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
B7683361430Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-06-19
B7683363220Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-06-19
B7683439140Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-04-24
B7682462200Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-04-23
B7682461610Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-12-12
B7685612810Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-12-12
B7685255060Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685255120Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685257350Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685257670Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685255190Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-09-24
B7685257320Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-09-24
B7685612550Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-07-23
B7685661130Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-06-13
B7682460140Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-05-30
B7683359530Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-05-30