DEVICE: NA (06932503548519)
Device Identifier (DI) Information
NA
HBF55-11023180
In Commercial Distribution
HBF55-11023180
Micro-Tech (Nanjing) Co., Ltd.
HBF55-11023180
In Commercial Distribution
HBF55-11023180
Micro-Tech (Nanjing) Co., Ltd.
Oval, without spike, 2.3*1800 mm
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KGE | Forceps, Biopsy, Electric |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K160625 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0d9a47ca-514f-48fe-b1d6-5fe2e3052833
July 06, 2018
3
July 01, 2016
July 06, 2018
3
July 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
26932503548513 | 10 | 16932503548516 | In Commercial Distribution | case | |
16932503548516 | 10 | 06932503548519 | In Commercial Distribution | box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined