DEVICE: Olympus (04953170049118)

Device Identifier (DI) Information

Olympus
FD-7C-1
In Commercial Distribution

OLYMPUS MEDICAL SYSTEMS CORP.
04953170049118
GS1

1
711789789 *Terms of Use
FD-7C-1.B HOT BIOPSY FORCEPS 2.0MM
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
Flexible endoscopic biopsy forceps, reusable 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 reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
FGA Kit, nephroscope
KGE FORCEPS, BIOPSY, ELECTRIC
FAJ Cystoscope and accessories, flexible/rigid
KNS Unit, electrosurgical, endoscopic (with or without accessories)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K993041 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

253f3532-518d-4bf6-96ca-9ed544e2c396
October 08, 2018
4
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
14953170049115 1 04953170049118 In Commercial Distribution
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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)

[?]
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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