DEVICE: Ambler Surgical (00190660041182)
Device Identifier (DI) Information
Ambler Surgical
Biopsy forceps
In Commercial Distribution
96-447
AMBLER SURGICAL CORP.
Biopsy forceps
In Commercial Distribution
96-447
AMBLER SURGICAL CORP.
Biopsy forceps, rotatable, double-action, 5.0mm diameter, 330.0mm working length, straight tips, sharp oval cups, 2 pinholes, carbon fiber ring handle, HF connection
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
Yes | |
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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? |
---|---|---|---|---|
35802 | Otologic clamp |
A hand-held manual surgical instrument designed to grasp internal ear structures (e.g., a bone of the ossicles) during an ear/nose/throat (ENT) procedure. It typically has a self-retaining, scissors-like design with ring handles and is made of high-grade stainless steel. It is available in various sizes and blade designs that may utilize carbide inserts. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KAE | FORCEPS, ENT |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
bbd5e664-8003-4b61-84ee-898aaa911d04
January 15, 2021
1
January 07, 2021
January 15, 2021
1
January 07, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
+1(888)407-0006
0
sales@amblersurgical.com
sales@amblersurgical.com