FDA.reportPublic FDA data

RD® QUICK LOAD®

Primary DI
00850200006162
Brand
RD® QUICK LOAD®
Company
LSI Solutions, Inc.
Model
021010
Catalog number
021010
Device description
"RD® QUICK LOAD® SURGICAL SUTURE, 0 POLYESTER, NON-ABSORBABLE, 53"", GREEN, BRAIDED"
Published
2015-12-04
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GASSuture, Nonabsorbable, Synthetic, Polyester

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GASSuture, Nonabsorbable, Synthetic, PolyesterGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031443000
K100593000
K203120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031443000LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTSLsi Solutions2003-06-18NEW
K100593000SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEMELsi Solutions, Inc.2010-10-13GAW
K203120000RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 PolypropyleneLsi Solutions, Inc.2020-11-24GAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850200006169PackageGS112In Commercial Distribution
00850200006162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085020000616910850200006169
00850200006162008502000061628502000061620850200006162

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, multifilamentA multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length53Inch
Outer Diameter0.37Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store suture at room temperature. Avoid prolonged exposure to elevated temperatures.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
866-575-3493customerservice@lsisolutions.com
+1(866)575-3493customerservice@lsisolutions.com
+1(866)575-3493regulatorydpt@lsisolutions.com

Regulatory Flags#

DUNS number
603420183
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850012846703PicoDriver0234700234702026-04-28
00850012846246MD™ QUICK LOAD®0231600231602022-12-22
00850012846529RD® QUICK LOAD®0233870233872025-07-09
00850012846543RAM® COR-SUTURE® QUICK LOAD®0234070234072025-07-28
00850200006148RD® QUICK LOAD®0209790209792015-12-04
00850200006346COR-SUTURE® QUICK LOAD®0218610218612016-05-12
00850200006353COR-SUTURE® QUICK LOAD®0218620218622016-05-12
00850200006407RAM® COR-SUTURE® QUICK LOAD®0220900220902018-06-02
00850200006438RAM® COR-SUTURE® QUICK LOAD®0220470220472018-06-02
00850200006445RAM® COR-SUTURE® QUICK LOAD®0220390220392020-03-13
00850200006452RAM® COR-SUTURE® QUICK LOAD®0223350223352020-03-13
00850200006469RAM® COR-SUTURE® QUICK LOAD®0223200223202020-03-13
00850200006476RAM® COR-SUTURE® QUICK LOAD®0223250223252020-03-13
00850200006483RAM® COR-SUTURE® QUICK LOAD®0223400223402020-03-13
00850200006766RAM® COR-SUTURE® QUICK LOAD®0226680226682020-03-13
00850200006773RAM® COR-SUTURE® QUICK LOAD®0226710226712020-03-13
00850200006780RAM® COR-SUTURE® QUICK LOAD®0226740226742020-03-13
00850200006797RAM® COR-SUTURE® QUICK LOAD®0226800226802020-03-13
00850200006803RAM® COR-SUTURE® QUICK LOAD®0226830226832020-03-13
00850200006810RAM® COR-SUTURE® QUICK LOAD®0226860226862020-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840124514126TopLockFUSION ORTHOPEDICS, LLCGAS2025-11-18
00840124514188TopLockFUSION ORTHOPEDICS, LLCGAS2025-11-18
00840124524774TopLockFUSION ORTHOPEDICS, LLCGAS2025-11-18
00840124521339TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00840124521346TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00840124521353TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00840124521360TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00850012846543RAM® COR-SUTURE® QUICK LOAD®LSI Solutions, Inc.GAS2025-07-28
10850012846540RAM® COR-SUTURE® QUICK LOAD®LSI Solutions, Inc.GAS2025-07-28
00840277408389PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408396PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408402PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408419PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408426RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408433RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408440RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408457RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277409133PolyBondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277409140PolyBondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277409416RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277409430RiverBondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408386PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408393PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408409PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408416PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408423RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408430RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408447RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408454RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277409130PolyBondRIVERPOINT MEDICAL, LLCGAS2025-06-18