Nordson Medical

GUDID 10815634020952

Custom OsteoPrecision Accessory kit

MICROMEDICS, INC.

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Primary Device ID10815634020952
NIH Device Record Keyccbcbdee-9968-4915-9413-d248f590bcbb
Commercial Distribution StatusIn Commercial Distribution
Brand NameNordson Medical
Version Model NumberPKG327
Company DUNS066839630
Company NameMICROMEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815634020955 [Primary]
GS110815634020952 [Package]
Contains: 00815634020955
Package: Inner Pack [1 Units]
In Commercial Distribution
GS120815634020959 [Package]
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-12
Device Publish Date2021-04-02

On-Brand Devices [Nordson Medical]

10815634020884DUAL SPRAY PROCEDURE KIT
10815634021126RATIO PROCEDURE KIT 11:1 RATIO
10815634021188Endoscopic Applicator with Mixing Tip, 5mm x 40cm, 1:1 Ratio
10815634020952Custom OsteoPrecision Accessory kit
10815634021263DuploTip with Snap Lock, 5mm x 32cm
10815634021218Spray Applicator Kit
10815634020990NuVasive Graft Delivery Syringe
10815634020914Applicator Assembly procedure kit with spray tips
10815634021119Viscous-Spray II, 11:1 Ratio Applicator Assembly with Dual Spray Tip
00815634021105Viscous-Spray Low Viscosity Ratio Applicator with 3cm Mixing/Spray Tip
00815634021099Viscogel High Viscosity Ratio Applicator with 10cm Mixing Tip
10815634021072Applicator Tip, Dual Cannula, 20 ga x 4'' (10.2cm)
10815634020976Applicator Tip, Dual Cannula, 20 ga x 2' (5.1 cm)
10815634020778Applicator Tip Dual Spray
10815634020969Applicator Assembly 10cc Syringe 1:1 Ratio
10815634020921Aerosol Applicator Kit W/Tips, 11:1 Ratio
10815634020877RATIO PROCEDURE KIT 11:1 RATIO
00815634021129Applicator Tip, Single Spray
10815634021041Gasless Applicator 25CM, OUS - Baxter
10815634021034Gasless Applicator Open, OUS - Baxter
10815634021201Baxter Replacement Tips
10815634021065Gasless Applicator 40CM, OUS - Baxter
10815634021089MALLEABLE APPLICATOR TIP, STERILE, 0.160in OD x 5.51in L

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