DEVICE: Single Use Electrosurgical Hemostatic Forceps (04953170208430)

Device Identifier (DI) Information

Single Use Electrosurgical Hemostatic Forceps
FD-410LR
In Commercial Distribution

OLYMPUS MEDICAL SYSTEMS CORP.
04953170208430
GS1

1
711789789 *Terms of Use
Single Use Electrosurgical Hemostatic Forceps
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
Flexible endoscopic biopsy forceps, single-use A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KGE FORCEPS, BIOPSY, ELECTRIC
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K062517 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

b214025d-85df-40b4-9bca-732582e22fd6
July 06, 2018
3
September 21, 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
14953170208437 1 04953170208430 In Commercial Distribution
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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
Yes
No
No CLOSE

Customer Contact

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