SpineSmith Fusionary Graft Delivery System 0861-0003

GUDID 00817771027408

Celling Injection Kit

Celling Biosciences

Bone graft syringe Bone graft syringe Bone graft syringe, single-use Bone graft syringe, single-use Bone graft syringe, single-use Bone graft syringe, single-use Bone graft syringe, single-use Bone graft syringe, single-use Bone graft syringe, single-use
Primary Device ID00817771027408
NIH Device Record Key4b5cccf4-6745-4a6a-8bf4-789aa8dc1eda
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpineSmith Fusionary Graft Delivery System
Version Model Number0861-0003
Catalog Number0861-0003
Company DUNS021560394
Company NameCelling Biosciences
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone512-637-6745
EmailCustomerService@CellingBiosciences.com
Phone512-637-6745
EmailCustomerService@CellingBiosciences.com
Phone512-637-6745
EmailCustomerService@CellingBiosciences.com
Phone512-637-6745
EmailCustomerService@CellingBiosciences.com
Phone512-637-6745
EmailCustomerService@CellingBiosciences.com
Phone512-637-6745
EmailCustomerService@CellingBiosciences.com
Phone512-637-6745
EmailCustomerService@CellingBiosciences.com
Phone512-637-6745
EmailCustomerService@CellingBiosciences.com
Phone512-637-6745
EmailCustomerService@CellingBiosciences.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817771027408 [Primary]

FDA Product Code

KDDKit, Surgical Instrument, Disposable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-12-29

On-Brand Devices [SpineSmith Fusionary Graft Delivery System]

00817771027613ART GFC Kit
00817771027408Celling Injection Kit
00817771027392120cc: Graft Delivery Kit
00817771027385Graft Delivery Kit
00817771027378Blood Draw Kit
00817771027361Small Volume Bone Marrow Aspiration Kit
00817771027354Bone Marrow Aspiration Kit
00817771027347BMA Kit Large Volume
00817771027330BMA Kit Classic
00817771027323BMA Kit Standard
00817771027316BMA Kit with 30cc Syringes

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