DEVICE: Olympus (04953170043130)

Device Identifier (DI) Information

Olympus
MH-544
In Commercial Distribution

OLYMPUS MEDICAL SYSTEMS CORP.
04953170043130
GS1

5
711789789 *Terms of Use
"MH-544 AUTOCLAVABLE SEALING CAP FOR A LL"
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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
Surgical instrument seal/seal maintenance set A seal/collection of seals (e.g., O-rings, shaped or viscous gaskets) intended to be used to replace a damaged sealing component in the maintenance of certain endoscopes, microscopes, injectors, or other surgical instruments. It may include supportive hand tools (screwdrivers). It is not a laparoscopic access cannula seal.
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FDA Product Code

[?]
Product Code Product Code Name
ODD Endoscopic retrograde cholangiopancreatography (ERCP) cannula
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K950729 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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

9b005beb-2907-47ff-9a14-aab68fc79d33
October 22, 2018
5
September 21, 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
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: 84953170043136 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)401-1086
xx@xx.xx
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