DEVICE: Bifurcated Needles for Allergy Skin Testing (10868652000208)

Device Identifier (DI) Information

Bifurcated Needles for Allergy Skin Testing
PB-02000-000-00
In Commercial Distribution
PB-02000-000-00
ROECHLING MEDICAL LANCASTER, LLC
10868652000208
GS1

100
130756638 *Terms of Use
Bifurcated Needles for Allergy Skin Testing
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45539 Allergy testing lancet
A sterile device with a sharp triangular cutting edge at the distal end designed to manually breach the epidermis to facilitate the diagnosis of allergic reactions in skin allergy testing performed by an allergist or other healthcare professional. It is held between the fingertips and pressed transiently, but firmly (not jabbed), at right angles through a drop of an allergen extract into the flexor side of the forearm of a suspected allergic individual. The tip penetrates only the most superficial layers of the skin allowing a small volume of the allergen extract to enter the skin and diffuse into the skin layers below. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LDH System, Delivery, Allergen And Vaccine
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K031630 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

3eceacd4-3028-479e-a288-9ae365ecb263
September 29, 2020
1
September 21, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 00868652000201 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
717-335-3700
nadine.weiss@roechling-medical.us
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