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 Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet

• Primary Device ID: 10868652000208
• NIH Device Record Key: 3eceacd4-3028-479e-a288-9ae365ecb263
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bifurcated Needles for Allergy Skin Testing
• Version Model Number: PB-02000-000-00
• Catalog Number: PB-02000-000-00
• Company DUNS: 130756638
• Company Name: ROECHLING MEDICAL LANCASTER, LLC
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 717-335-3700
• Email: nadine.weiss@roechling-medical.us
• Phone: 717-335-3700
• Email: nadine.weiss@roechling-medical.us
• Phone: 717-335-3700
• Email: nadine.weiss@roechling-medical.us
• Phone: 717-335-3700
• Email: nadine.weiss@roechling-medical.us
• Phone: 717-335-3700
• Email: nadine.weiss@roechling-medical.us
• Phone: 717-335-3700
• Email: nadine.weiss@roechling-medical.us
• Phone: 717-335-3700
• Email: nadine.weiss@roechling-medical.us
• Phone: 717-335-3700
• Email: nadine.weiss@roechling-medical.us
• Phone: 717-335-3700
• Email: nadine.weiss@roechling-medical.us
• Phone: 717-335-3700
• Email: nadine.weiss@roechling-medical.us
• Phone: 717-335-3700
• Email: nadine.weiss@roechling-medical.us
• Phone: 717-335-3700
• Email: nadine.weiss@roechling-medical.us
• Phone: 717-335-3700
• Email: nadine.weiss@roechling-medical.us
• Phone: 717-335-3700
• Email: nadine.weiss@roechling-medical.us
• Phone: 717-335-3700
• Email: nadine.weiss@roechling-medical.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868652000201 [Unit of Use]
GS1	10868652000208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031630

FDA Product Code

• LDH: System, Delivery, Allergen And Vaccine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-29
• Device Publish Date: 2020-09-21

Devices Manufactured by ROECHLING MEDICAL LANCASTER, LLC

• 10868652000208 - Bifurcated Needles for Allergy Skin Testing: 2020-09-29Bifurcated Needles for Allergy Skin Testing
• 10868652000208 - Bifurcated Needles for Allergy Skin Testing: 2020-09-29 Bifurcated Needles for Allergy Skin Testing
• 10868652000222 - Bifurcated Vaccinating Needles: 2020-09-29 Bifurcated Vaccinating Needles