DEVICE: ERBE (04050147012806)

Device Identifier (DI) Information

ERBE
20325-205
Not in Commercial Distribution
20325-205
Erbe Elektromedizin GmbH
04050147012806
GS1
September 20, 2023
1
316116623 *Terms of Use
Hybrid OFP & EndoStat Tubing/ Cap Set for Olympus® Scope
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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?
46102 Surgical irrigation tubing set, single-use
A collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OCX endoscopic irrigation/suction system
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K103696 000
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: 3.500 Meter
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Device Record Status

6dc7d6bf-f799-45d6-a019-6ad620f9dfaa
September 21, 2023
7
December 16, 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
04050147013193 7 04050147012806 2023-09-20 Not in Commercial Distribution Level: 1
04050147013209 5 04050147013193 2023-09-20 Not in Commercial Distribution Level: 2
04050147022065 10 04050147012806 2023-09-20 Not in Commercial Distribution Level: 1
04050147022072 3 04050147022065 2023-09-20 Not in Commercial Distribution Level: 2
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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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