FDA.reportPublic FDA data

Combined Adapter

Primary DI
00850034511016
Brand
Combined Adapter
Company
Bimini Technologies LLC
Model
ADAPT/PURE
Device description
The Puregraft Combined Adapter is an autoclavable, reusable medical device used for the transfer of soft tissue and fluid between syringes and Puregraft products during general surgical and plastic surgery procedures.
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
00850034511016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850034511016008500345110168500345110160850034511016

GMDN Terms#

Term, Definition table
TermDefinition
Collection syringe adaptor, reusableA small device designed be placed over the top of a syringe to encase the tip of the syringe as means to modify the shape and the size of the syringe tip. It is typically made of stainless steel or a durable polymer material and its shape and size mimics that of the appropriately-matched syringe barrel (i.e., 60 cc, 30 cc, 10 cc versions of a Toomey style syringe). It is typically used for the transfer of human tissue or other substances from one container to another during plastic and reconstructive surgery, cosmetic surgery, or general surgery procedures. This is a reusable device.

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
10888277688988MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689190MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689206MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689213MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689220MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689237MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689244MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
20888277688978MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10080196320899MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321407MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321414MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321438MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321452MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321469MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321476MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321483MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321490MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10888277689183MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321445MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-24
00190776431587MillenniumAvalign Technologies, Inc.MDM2026-09-22
00850088713886PRINCETONPrinceton Medical Group, Inc.MDM2026-09-22
00850088713893PRINCETONPrinceton Medical Group, Inc.MDM2026-09-22
00888867574489Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574496Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574502Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574519Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574526Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574533Arthrex®ARTHREX, INC.MDM2026-09-18
10888277688896MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688902MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18