FDA.reportPublic FDA data

Puregraft Instrument Set

Primary DI
00850034511030
Brand
Puregraft Instrument Set
Company
Bimini Technologies LLC
Model
550/IS SST
Device description
Is composed of the Puregraft Easel and Puregraft Slider. Both components are made of autoclavable stainless steel. The Easel holds the Puregraft Bag in place, and the Slider tool is used on the exterior of the Puregraft Bag to compress and facilitate the movement of liquids through the filter mesh and into the Drain Bag.
Published
2022-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00850034511030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850034511030008500345110308500345110300850034511030

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tableA table used for laying out sterile surgical instruments, sutures, and other utensils/items required during an operation or intervention. It is designed to include an appropriate, e.g., stainless steel, top or surface with no crevices, screws or rivets, and most tables include telescoping pedestals for height adjustment and swivel caster bases. This table is used in the so-called "sterile area" of the operation site and in some cases may be attached to the operating table.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
076649467
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850034511047Puregraft SYNCPURE/SYNC2026-02-24
00850034511023Puregraft 850 System Twin Pack850/TWIN2024-08-22
00850034511108Puregraft 50 System50/PURE2022-04-01
00850034511139Puregraft 250 System250/PURE2022-04-01
00850034511177Puregraft 250 System250/PURE2022-04-01
00850034511191Puregraft 850 System850/PURE2022-04-01
00850034511696Puregraft 50 System50/PURE2024-01-11
00850034511252Dermapose RefreshREFRESH2022-02-09
00850034511276AutoPose RestoreABS-101035-12022-02-09
00850034511993DIRECT2 LidPVL/PURE22024-10-04
00850034511009Puregraft 850 System Twin Pack850/TWIN2024-08-22
00850034511436Puregraft Serene Breast Implant335CC2024-03-28
00850034511092Puregraft Serene Breast Implant210CC2024-03-28
00850034511283Puregraft Serene Breast Implant270CC2024-03-28
00850034511368Puregraft Serene Breast Implant300CC2024-03-28
00850034511641Puregraft Serene Breast Implant370CC2024-03-28
00850034511665Puregraft Serene Breast Implant405CC2024-03-28
00850034511689Puregraft Serene Breast Implant440CC2024-03-28
00850034511764Puregraft Serene Breast Implant475CC2024-03-28
00850034511788Puregraft Serene Breast Implant515CC2024-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091988ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-22
00198506093470ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-22
00840456215753JMUJMU DENTAL, INCMDM2026-07-22
00840456218600JMUJMU DENTAL, INCMDM2026-07-22
00840456218617JMUJMU DENTAL, INCMDM2026-07-22
00190776403744MillenniumAvalign Technologies, Inc.MDM2026-07-21
00810005668125TrigonNVision Biomedical Technologies, Inc.MDM2026-04-24
00810005667227TrigonNVision Biomedical Technologies, Inc.MDM2025-12-19
00810135963169ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135963183ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135963251ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135963275ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135962865TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962889TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962896TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
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00810135962919TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
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00810135962650TrigonNVision Biomedical Technologies, Inc.MDM2025-05-27
00810135962667TrigonNVision Biomedical Technologies, Inc.MDM2025-05-27