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
00889858640800PliaFX FloBL-2200-00BL-2200-002025-01-01
00889858640817PliaFX FloBL-2200-01BL-2200-012025-01-01
00889858640824PliaFX FloBL-2200-02BL-2200-022025-01-01
00889858640831PliaFX FloBL-2200-05BL-2200-052025-01-01
00889858640848PliaFX FloBL-2200-10BL-2200-102025-01-01
00889858640855PliaFX FloBL-2225-00BL-2225-002025-01-01
00889858640862PliaFX FloBL-2225-01BL-2225-012025-01-01
00889858640879PliaFX FloBL-2225-02BL-2225-022025-01-01
00889858640886PliaFX FloBL-2225-05BL-2225-052025-01-01
00889858640893PliaFX FloBL-2225-10BL-2225-102025-01-01
00889858002714VESUVIUS™4104-K0010DP-014104-K0010DP2015-09-24
00889858002752VESUVIUS™4104-K0025DP-014104-K0025DP2015-09-24
00889858002790VESUVIUS™4104-K0050DP-014104-K0050DP2015-09-24
00889858002813VESUVIUS™4104-K0100DP-014104-K0100DP2015-09-24
00889858625708Optium®TGEL03TGEL032020-12-07
00889858450546Optium®TGEL01TGEL012015-09-24
00889858450560Optium®TGEL05TGEL052015-09-24
00889858450584Optium®TGEL10TGEL102015-09-24
00889858517683Optium®TPUT01TPUT012015-09-24
00889858517706Optium®TPUT02TPUT022015-09-24

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Primary DI, Brand, Company table
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