Kinn Automatic Volume Management System

Primary DI
00628774388164
Brand
Kinn Automatic Volume Management System
Company
Vessl Prosthetics Inc
Model
KIT-0004
Device description
Kinn System, LT Dial, Soft, LAM PL
Published
2026-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00628774388164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00628774388164006287743881646287743881640628774388164

GMDN Terms

TermDefinition
External lower-limb prosthesis structural/alignment componentA component of an external lower limb prosthesis [hip, knee, or ankle-foot prosthesis] designed as: 1) a structural element to connect and maintain the structural integrity between the components of the prosthesis [e.g., between a socket and a knee joint prosthesis]; and/or 2) an alignment element to enable adjustment of the orientation of the prosthesis components relative to each other and to the patient (e.g., mediolateral shift, anteroposterior tilt). It may be in the form of a tube, pylon, adaptor, attachment block, clamp, pyramid, socket anchor, plate, or other design, and is intended to remain an integral part of the fitted prosthesis.

Sterilization Methods

Method

Regulatory Flags

DUNS number
243324078
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00628774388003Kinn Automatic Volume Management SystemKIT-00062026-03-02
00628774388010Kinn Automatic Volume Management SystemKIT-00122026-03-02
00628774388041Kinn Automatic Volume Management SystemKIT-00012026-03-02
00628774388058Kinn Automatic Volume Management SystemKIT-00022026-03-02
00628774388171Kinn Automatic Volume Management SystemKIT-00052026-03-02
00628774388188Kinn Automatic Volume Management SystemKIT-00032026-03-02
00628774388195Kinn Automatic Volume Management SystemKIT-00112026-03-02
00628774388201Kinn Automatic Volume Management SystemKIT-00102026-03-02
00628774388218Kinn Automatic Volume Management SystemKIT-00092026-03-02
00628774388225Kinn Automatic Volume Management SystemKIT-00082026-03-02
00628774388232Kinn Automatic Volume Management SystemKIT-00072026-03-02