Automatic Cutting Needle NAC-1816

GUDID 10813079020841

18 ga (1.3mm) x 16 cm

REMINGTON MEDICAL, INC.

Prostate biopsy needle Prostate biopsy needle
Primary Device ID10813079020841
NIH Device Record Keye85fd6ed-fdbb-44dd-82bf-60d148f422d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutomatic Cutting Needle
Version Model NumberNAC-1816
Catalog NumberNAC-1816
Company DUNS788472314
Company NameREMINGTON MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com

Device Dimensions

Needle Gauge18 Gauge
Needle Gauge18 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100813079020844 [Primary]
GS110813079020841 [Package]
Contains: 00813079020844
Package: Inner Carton [10 Units]
In Commercial Distribution
GS120813079020848 [Package]
Package: Shipping Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWINSTRUMENT, BIOPSY

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10813079020841]

Ethylene Oxide


[10813079020841]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-21

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1081307902095718 ga (1.3mm) x 20 cm
2081307902094718 ga (1.3mm) x 25 cm)
2081307902093018 ga (1.3mm) x 20 cm
2081307902092318 ga (1.3mm) x 16 cm
1081307902091918 ga (1.3mm) x 25 cm
1081307902090218 ga (1.3mm) x 20 cm
1081307902089618 ga (1.3mm) x 16 cm
2081307902088618 ga (1.3mm) x 25 cm
1081307902087218 ga (1.3mm) x 20 cm
1081307902086518 ga (1.3mm) x 16 cm
1081307902085818 ga (1.3mm) x 20 cm
1081307902084118 ga (1.3mm) x 16 cm
1081307902083414 ga (2.1mm) x 10 cm
1081307902082718 ga (1.3mm) x 25 cm
2081307902081718 ga (1.3mm) x 20 cm
2081307902080014 ga (2.1mm) x 10 cm

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