FDA.reportPublic FDA data

RAM®

Primary DI
00850200006704
Brand
RAM®
Company
LSI Solutions, Inc.
Model
080228
Catalog number
080228
Device description
RAM® RACK Suture Management System
Published
2020-03-13
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
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850200006701PackageGS13In Commercial Distribution
00850200006704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085020000670110850200006701
00850200006704008502000067048502000067040850200006704

GMDN Terms#

Term, Definition table
TermDefinition
Operative-site suture holderA device designed to hold suture threads to facilitate their manipulation, positioning and differentiation around the operative site during a surgical procedure. It typically has a circular, oval, or curved shape with grooves or other connecting elements, and is stabilized by attachment to a surgical drape; it may also be attached to an invasive surgical retractor. 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
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
B382SD903260200Surgical DirectSurgical Direct, Inc.DWS2026-10-28
00724995264819Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264826Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264833Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264840Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264857Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265564Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265571Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265588Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995278977V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279004V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279042V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279059V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279066V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279080V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280093V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280826V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280871V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280895V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280901V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280918V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280925V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280987V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281045V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281229V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281243V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281250V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281267V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281274V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281281V. MuellerSTERIS Deutschland GmbHDWS2026-10-27