FDA.reportPublic FDA data

RAPORT™ KIT

Primary DI
00850012846475
Brand
RAPORT™ KIT
Company
LSI Solutions, Inc.
Model
081720
Catalog number
081720
Device description
RAPORT™ KIT RP-100™
Published
2025-07-09
Public version status
New
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
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850012846472PackageGS16In Commercial Distribution
00850012846475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001284647210850012846472
00850012846475008500128464758500128464750850012846475

GMDN Terms#

Term, Definition table
TermDefinition
Suture/ligature tightener, single-useA hand-held manual surgical instrument intended for the in situ tightening of a suture/ligature loop or a suture between a set of suture anchors (not included) during open and/or minimally-invasive surgery (e.g., vascular or gastrointestinal surgery). The suture is intended to be loaded into the device, which typically includes a sliding mechanism or a rigid tube with an internal wire loop for controlled manual tightening; some types may include a non-penetrating fastening device to secure suture ends. This is a single-use device.

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850012846741JNW URTRAC0813000813002026-08-21
00850012846710ValveVault0820650820652026-07-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433536MillenniumAvalign Technologies, Inc.MDM2026-10-06
00190776434311MillenniumAvalign Technologies, Inc.MDM2026-10-06
00810220800584Adler Instrument CompanyAdler, Inc.MDM2026-09-30
00190776432775MillenniumAvalign Technologies, Inc.MDM2026-09-29
00888867618961Arthrex®ARTHREX, INC.MDM2026-09-28
00888867621237Arthrex®ARTHREX, INC.MDM2026-09-28
10888277689251MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689268MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689282MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689299MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689305MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689312MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689329MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689336MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689343MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689350MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
20888277689272MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277688988MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689190MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689206MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689213MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689220MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689237MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689244MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
20888277688978MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10080196320899MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321407MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321414MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321438MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321452MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25