FDA.reportPublic FDA data

Dermapose Access

Primary DI
00863445000369
Brand
Dermapose Access
Company
PUREGRAFT LLC
Model
ACCESS
Published
2020-08-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MUUSystem, Suction, Lipoplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUUSystem, Suction, LipoplastyGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10863445000366PackageGS118Not in Commercial Distribution
00863445000369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086344500036610863445000366
00863445000369008634450003698634450003690863445000369

GMDN Terms#

Term, Definition table
TermDefinition
Autologous adipose tissue reinjection setA collection of devices which includes an invasive cannula/needle, intended for both harvesting fat tissue from a patient (liposuction) and subsequently injecting the fat tissue into the patient from whom it was taken (autologous lipotransfer) as part of a surgical procedure (e.g., reconstructive/cosmetic, orthopaedic, spinal); it may additionally be intended to process the adipose tissue. In addition to needles/cannulae, it includes syringes, accessories (e.g., caps, connectors), and may include collection/processing devices (e.g., filtration bag). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep package dry

Regulatory Flags#

DUNS number
079508934
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860407002218Puregraft250250/PURE2019-12-06
00860407002225Puregraft850850/PURE2019-05-14
00863445000307Puregraft250250/PURE2016-09-22
00863445000314Puregraft850850/PURE2016-09-22
00863445000338Puregraft5050/PURE2016-09-22
00863445000352Dermapose RefreshREFRESH2020-08-24
00850009190130AutoPose RestoreABS-101035-12023-01-04
00860407002287Puregraft MicroFat Transfer Kit (19G)50/MICRO192020-08-24
00860407002294Puregraft MicroFat Transfer Kit (21G)50/MICRO212020-08-24
00860407002232Dermapose Refresh Syringe StandSTAND2020-08-21
00860407002270Puregraft MicroFat Transfer Kit50/MICRO2020-03-18
10863445000359Dermapose RefreshREFRESH2020-08-24
10863445000366Dermapose AccessACCESS2020-08-24
10860407002215Puregraft250250/PURE2019-12-06
10860407002222Puregraft850850/PURE2019-05-14
20863445000301Puregraft250250/PURE2016-09-22
10863445000311Puregraft850850/PURE2016-09-22
00863445000345Puregraft5050/PURE2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130455843Medco ManufacturingMedco Manufacturing LLCMUU2026-03-31
04260632793640TLA Tubing Liposat Pro plusMöller Medical GmbHMUU2026-02-27
04260632794043TLA Tubing Liposat Pro plusMöller Medical GmbHMUU2026-02-27
00850000712478Autoclavable Suction Jar with Hose Barb extension - 250mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712485Autoclavable Suction Jar with Hose Barb extension - 500mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712492Autoclavable Suction Jar with Hose Barb extension - 1000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712508Autoclavable Suction Jar with Hose Barb extension - 2000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712515Autoclavable Suction Jar with Hose Barb extension - 3000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00810130455812Medco ManufacturingMedco Manufacturing LLCMUU2026-01-15
00810130455829Medco ManufacturingMedco Manufacturing LLCMUU2026-01-15
00810130455485Medco ManufacturingMedco Manufacturing LLCMUU2025-09-11
00810130455195Medco ManufacturingMedco Manufacturing LLCMUU2025-06-26
00810130455201Medco ManufacturingMedco Manufacturing LLCMUU2025-06-26
08800052308909FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
08800052308886FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
08800052316904FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
00810130454839Medco ManufacturingMedco Manufacturing LLCMUU2025-02-27
00385640084987SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640084994SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085007SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085014SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085021SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
03760173235292DISPOSABLE FAT HARVESTING CANNULAAESTHETIC GROUPMUU2024-12-09
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGMUU2024-05-31
07612367003551Quiver 280mmMedela AGMUU2024-05-31
07612367003568Quiver 480mmMedela AGMUU2024-05-31
07612367003698Overflow protection deviceMedela AGMUU2024-05-31
07612367003735Reusable serial connectorMedela AGMUU2024-05-31
07612367003742Safety Set for railholderMedela AGMUU2024-05-31
07612367003896Tubing holder left sideMedela AGMUU2024-05-31