DEVICE: ERBE (04050147013100)

Device Identifier (DI) Information

ERBE
20350-220
In Commercial Distribution
20350-220
Erbe Elektromedizin GmbH
04050147013100
GS1

1
316116623 *Terms of Use
ERBELIFT® Flexible Probe O.D. 1.3mm x 2.6m
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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 catheter A sterile, flexible tube intended to non-invasively deliver a submucosal lifting solution into the submucosa of the gastrointestinal tract through a flexible endoscope during an endoscopic procedure (e.g., gastroscopy, colonoscopy) to lift a lesion, typically for subsequent excision. It is attached proximally to a dedicated pump and the distal end incorporates a mechanism for producing a very small laminar stream for needleless injection. This is a single-use device.
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FDA Product Code

[?]
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

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

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from heat and direct sunlight
Special Storage Condition, Specify: Keep dry
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Clinically Relevant Size

[?]
Size Type Text
Length: 2600.000 Millimeter
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Device Record Status

41fe3818-f412-4fd6-bcc3-758b71aed6d6
March 29, 2018
2
December 14, 2016
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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
04050147013780 16 04050147013773 In Commercial Distribution Level: 2
04050147013773 5 04050147013100 In Commercial Distribution Level: 1
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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: 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
Yes
No
No CLOSE

Customer Contact

[?]
+4970717550
info@erbe-med.com
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