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 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