DEVICE: NA (04715309129456)

Device Identifier (DI) Information

NA
OS265BA-1-W
In Commercial Distribution

PANPAC MEDICAL CORPORATION
04715309129456
GS1

1
657528899 *Terms of Use
These Cervical Dilators are especially useful in locating and dilating the external OS, the cervical canal and the internal OS. They are particularly valuable instruments to be used on post-menopausal patients with cervical stenosis.
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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
Corpus cavernosum dilator, single-use A sterile, hand-held, manual surgical instrument designed to dilate the corpora cavernosa of the penis prior to the insertion of a penile prosthesis. The device is rod-like in design and typically made of plastic; it is available in a set of graduated sizes that are applied in succession. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
HDQ Dilator, Cervical, Fixed Size
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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

17a13822-69e5-4e29-8b83-7fb13d3b2137
March 29, 2018
2
August 15, 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
04715309129364 50 04715309129456 In Commercial Distribution BOX
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+866286472242
service@panpac.com.tw
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