FDA.reportPublic FDA data

I/C Graft Chamber ®

Primary DI
00889858395434
Brand
I/C Graft Chamber ®
Company
LIFENET HEALTH
Model
GDS005T
Catalog number
GDS005T
Device description
IC Graft Chamber - 5 cc
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEYMotor, Surgical Instrument, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889858395434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889858395434008898583954348898583954340889858395434

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft syringeA sterile and calibrated hollow barrel (cylinder) containing a plunger, designed to prepare and deliver bone graft materials (e.g., autologous blood or bone marrow with allograft, autograft, demineralized bone, or synthetic/composite bone matrix graft materials) during an orthopaedic surgical procedure. With the use of a dedicated needle, it allows for the aspiration and mixing of the materials and their delivery to the surgical site. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-847-7831xx@xx.xx

Regulatory Flags#

DUNS number
121828156
Device count
1
HCT/P
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889858118491FlexiGRAFT®FGL09066FGL090662015-09-24
00889858638449FlexiGRAFT®FDL090175FDL2023-01-31
00889858638456FlexiGRAFT®FDL090180FDL2023-01-31
00889858638463FlexiGRAFT®FDL090185FDL2023-01-31
00889858638470FlexiGRAFT®FDL090190FDL2023-01-31
00889858638487FlexiGRAFT®FDL090195FDL2023-01-31
00889858638494FlexiGRAFT®FDL090200FDL2023-01-31
00889858638500FlexiGRAFT®FDL090205FDL2023-01-31
00889858638517FlexiGRAFT®FDL090210FDL2023-01-31
00889858638524FlexiGRAFT®FDL090215FDL2023-01-31
00889858638531FlexiGRAFT®FDL095175FDL2023-01-31
00889858638548FlexiGRAFT®FDL095180FDL2023-01-31
00889858638555FlexiGRAFT®FDL095185FDL2023-01-31
00889858638579FlexiGRAFT®FDL095195FDL2023-01-31
00889858638586FlexiGRAFT®FDL095200FDL2023-01-31
00889858638593FlexiGRAFT®FDL095205FDL2023-01-31
00889858638609FlexiGRAFT®FDL095210FDL2023-01-31
00889858638616FlexiGRAFT®FDL095215FDL2023-01-31
00889858638623FlexiGRAFT®FDL1001752023-01-31
00889858638630FlexiGRAFT®FDL100180FDL2023-01-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05430003362112WAW SLIM HANDPIECEDevroye Instruments BelgiumGEY2026-09-21
05430003362242WAW CHARGING STATIONDevroye Instruments BelgiumGEY2026-09-21
05430003362259WAW Duo FUE SystemDevroye Instruments BelgiumGEY2026-09-21
05430003362280WAW SOFTWAREDevroye Instruments BelgiumGEY2026-09-21
00889024712300Z1 POSTERIOR HAMMR ADPTRZimmer, Inc.GEY2026-08-25
00889024712317Z1 ANTERIOR HAMMR ADPTRZimmer, Inc.GEY2026-08-25
05051471225565De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-08-03
05051471225541De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-08-01
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05051471223639De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-01
05051471221697De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
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05051471221710De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
10817417021323AsepticoASEPTICO, INC.GEY2026-04-08
10817417021330AsepticoASEPTICO, INC.GEY2026-04-08
10845854013144ERGOConmed CorporationGEY2026-03-24
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