Bifurcated Needles for Allergy Skin Testing PB-02000-000-00

GUDID 10868652000208

Bifurcated Needles for Allergy Skin Testing

ROECHLING MEDICAL LANCASTER, LLC

Allergy testing lancet
Primary Device ID10868652000208
NIH Device Record Key3eceacd4-3028-479e-a288-9ae365ecb263
Commercial Distribution StatusIn Commercial Distribution
Brand NameBifurcated Needles for Allergy Skin Testing
Version Model NumberPB-02000-000-00
Catalog NumberPB-02000-000-00
Company DUNS130756638
Company NameROECHLING MEDICAL LANCASTER, LLC
Device Count100
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone717-335-3700
Emailnadine.weiss@roechling-medical.us
Phone717-335-3700
Emailnadine.weiss@roechling-medical.us
Phone717-335-3700
Emailnadine.weiss@roechling-medical.us
Phone717-335-3700
Emailnadine.weiss@roechling-medical.us
Phone717-335-3700
Emailnadine.weiss@roechling-medical.us
Phone717-335-3700
Emailnadine.weiss@roechling-medical.us
Phone717-335-3700
Emailnadine.weiss@roechling-medical.us
Phone717-335-3700
Emailnadine.weiss@roechling-medical.us
Phone717-335-3700
Emailnadine.weiss@roechling-medical.us
Phone717-335-3700
Emailnadine.weiss@roechling-medical.us
Phone717-335-3700
Emailnadine.weiss@roechling-medical.us
Phone717-335-3700
Emailnadine.weiss@roechling-medical.us
Phone717-335-3700
Emailnadine.weiss@roechling-medical.us
Phone717-335-3700
Emailnadine.weiss@roechling-medical.us
Phone717-335-3700
Emailnadine.weiss@roechling-medical.us

Device Identifiers

Device Issuing AgencyDevice ID
GS100868652000201 [Unit of Use]
GS110868652000208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDHSystem, Delivery, Allergen And Vaccine

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-29
Device Publish Date2020-09-21

Devices Manufactured by ROECHLING MEDICAL LANCASTER, LLC

10868652000208 - Bifurcated Needles for Allergy Skin Testing2020-09-29Bifurcated Needles for Allergy Skin Testing
10868652000208 - Bifurcated Needles for Allergy Skin Testing2020-09-29 Bifurcated Needles for Allergy Skin Testing
10868652000222 - Bifurcated Vaccinating Needles2020-09-29 Bifurcated Vaccinating Needles

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