DEVICE: Ambler Surgical (00190660030780)
Device Identifier (DI) Information
Ambler Surgical
Hegar uterine dilator
In Commercial Distribution
44-814
AMBLER SURGICAL CORP.
Hegar uterine dilator
In Commercial Distribution
44-814
AMBLER SURGICAL CORP.
Hegar uterine dilator, 8'', double-ended, set of 8 includes size 3.0mm/4.0mm to 17.0mm/18.0mm (44-816, 44-817, 44-818, 44-819, 44-820, 44-821, 44-822 and 44-823)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
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? |
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11266 | Fixed-diameter cervical dilator, reusable |
A rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HDQ | DILATOR, CERVICAL, FIXED SIZE |
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
3cdc3d97-89e7-45d2-a795-db655dcf9a93
January 12, 2021
1
January 04, 2021
January 12, 2021
1
January 04, 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