Puregraft Instrument Set

GUDID 00850034511030

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.

Bimini Technologies LLC

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Primary Device ID00850034511030
NIH Device Record Key639467a4-6b0f-41e1-8680-4be75a9e4435
Commercial Distribution StatusIn Commercial Distribution
Brand NamePuregraft Instrument Set
Version Model Number550/IS SST
Company DUNS076649467
Company NameBimini Technologies LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850034511030 [Primary]

FDA Product Code

MDMInstrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850034511030]

Moist Heat or Steam Sterilization


[00850034511030]

Moist Heat or Steam Sterilization


[00850034511030]

Moist Heat or Steam Sterilization


[00850034511030]

Moist Heat or Steam Sterilization


[00850034511030]

Moist Heat or Steam Sterilization


[00850034511030]

Moist Heat or Steam Sterilization


[00850034511030]

Moist Heat or Steam Sterilization


[00850034511030]

Moist Heat or Steam Sterilization


[00850034511030]

Moist Heat or Steam Sterilization


[00850034511030]

Moist Heat or Steam Sterilization


[00850034511030]

Moist Heat or Steam Sterilization


[00850034511030]

Moist Heat or Steam Sterilization


[00850034511030]

Moist Heat or Steam Sterilization


[00850034511030]

Moist Heat or Steam Sterilization


[00850034511030]

Moist Heat or Steam Sterilization


[00850034511030]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-17
Device Publish Date2022-02-09

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00850034511757 - Puregraft Serene Breast Implant2024-04-05 Saline Breast Implant
00850034511771 - Puregraft Serene Breast Implant2024-04-05 Saline Breast Implant

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