FDA.reportPublic FDA data

Dermapose Refresh Syringe Stand

Primary DI
00860407002232
Brand
Dermapose Refresh Syringe Stand
Company
PUREGRAFT LLC
Model
STAND
Published
2020-08-21
Public version status
Update
Distribution status
Not 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
00860407002232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860407002232008604070022328604070022320860407002232

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument containment holder, reusableA device intended to be used to safely contain a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] during surgery, to avoid damage to the instrument, and/or or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, telescopic tube, magnetic mat), may be attached to a surgical drape, and may be used for subsequent sterilization of the instrument(s); it is not a numbered tray and is not intended for counting of sharps. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079508934
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
00863445000369Dermapose AccessACCESS2020-08-24
00850009190130AutoPose RestoreABS-101035-12023-01-04
00860407002287Puregraft MicroFat Transfer Kit (19G)50/MICRO192020-08-24
00860407002294Puregraft MicroFat Transfer Kit (21G)50/MICRO212020-08-24
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
00190776426507MillenniumAvalign Technologies, Inc.MDM2026-08-18
00850088713541PRINCETONPrinceton Medical Group, Inc.MDM2026-08-14
00190776411534MillenniumAvalign Technologies, Inc.MDM2026-08-07
00190776423575MillenniumAvalign Technologies, Inc.MDM2026-08-07
00190776424435MillenniumAvalign Technologies, Inc.MDM2026-08-07
B382SD923286060Surgical DirectSurgical Direct, Inc.MDM2026-08-07
00190776422806MillenniumAvalign Technologies, Inc.MDM2026-08-03
00198506092350ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
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00198506093586ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
00198506090561ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
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00198506092046ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27