FDA.report

ASSI

Primary DI
00841645125907
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.AG104326
Device description
Lipo Roller 16.5cm, 40x80mm roller
Published
2020-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841645125907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645125907008416451259078416451259070841645125907

GMDN Terms

TermDefinition
Manual massager, home-useA manual (non-powered) device specifically designed to apply massage in the home. It is typically held in the hand of the user and drawn/rolled across the area of the body/muscles to be treated; it may also be designed to be placed on the floor for foot massage. The massaging components, e.g., roller heads or pads, may be interchangeable with others of different size and shape. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
055870299
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00841645143215ASSIASSI.BPNS243252023-08-18
00841645143222ASSIASSI.BPNS153392023-08-18
00841645142843ASSIASSI.SU632262023-08-11
00841645104988ASSIASSI.ACC1VB2023-08-11
00841645105091ASSIASSI.R1A2023-08-11
00841645105107ASSIASSI.ACC11AB2023-08-11
00841645105176ASSIASSI.DC1VB2023-08-11
00841645107385ASSIASSI.BS18822023-08-11
00841645108412ASSIASSI.005822023-08-11
00841645108474ASSIASSI.158842023-08-11
00841645108498ASSIASSI.16252023-08-11
00841645108542ASSIASSI.16632023-08-11
00841645108573ASSIASSI.16672023-08-11
00841645108634ASSIASSI.17002023-08-11
00841645108665ASSIASSI.17342023-08-11
00841645108696ASSIASSI.17402023-08-11
00841645108733ASSIASSI.17682023-08-11
00841645108771ASSIASSI.18002023-08-11
00841645108795ASSIASSI.18022023-08-11
00841645108856ASSIASSI.18322023-08-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
G453CFK1000PEAK MEDICALPeak Medical Distribution Inc.GEA2026-03-23
G453AR130PEAK MEDICALPeak Medical Distribution Inc.GEA2026-03-11
00810130456109Medco ManufacturingMedco Manufacturing LLCGEA2026-02-27
00850080243145T-Han Delivery SystemBONE SOLUTIONS, INC.GEA2026-02-13
00850080243152T-Han Delivery SystemBONE SOLUTIONS, INC.GEA2026-02-13
00850080243169T-Han Delivery SystemBONE SOLUTIONS, INC.GEA2026-02-13
20860002896964TalarusCannuflow, Inc.GEA2026-01-28
04058749082937NAFehling Instruments GmbH & Co. KGGEA2026-01-28
00840329836795N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-16
00840329837013N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-16
07630542741012CannulaMedacta International SAGEA2026-01-16
07630542741029CannulaMedacta International SAGEA2026-01-16
07630542741036CannulaMedacta International SAGEA2026-01-16
07630542746499CannulaMedacta International SAGEA2026-01-16
07630542746505CannulaMedacta International SAGEA2026-01-16
07630542746512CannulaMedacta International SAGEA2026-01-16
00840329836375N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836382N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836399N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836405N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836412N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836429N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836443N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836450N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836467N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836474N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836481N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836498N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836504N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836542N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15