DEVICE: ERBE (04050147013094)

Device Identifier (DI) Information

ERBE
20350-000
In Commercial Distribution

Erbe Elektromedizin GmbH
04050147013094
GS1

1
316116623 *Terms of Use
ERBELIFT® Hand Pump
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Endoscopic needleless submucosal lift pump A non-sterile, hand-held, manually-powered device designed to push a submucosal lifting solution, via an endoscopic needleless submucosal lift catheter, into the submucosa of the gastrointestinal tract during an endoscopic procedure (e.g., gastroscopy, colonoscopy) to lift a lesion, typically for subsequent excision. It is typically a pistol-shaped instrument, into which is loaded a standard prefilled syringe, designed to achieve high injection pressure. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
FBK Endoscopic Injection Needle, Gastroenterology-Urology
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Keep away from heat and direct sunlight
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

5cd17fbb-8149-42b2-8335-be31b61cc563
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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