DEVICE: Steriatrics (06938327904005)

Device Identifier (DI) Information

Steriatrics
100101
In Commercial Distribution
M101-SCT-ST
Shenzhen Boon Medical Supply Co., Ltd.
06938327904005
GS1
December 31, 9999
1
529174252 *Terms of Use
1-200ml Syringe 1-Fill Straw 1-60" Coiled Tubing
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
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?
16545 Angiography kit
A collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DXT Injector And Syringe, Angiographic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K151960 000
No 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

58f1b73d-162d-4599-b815-6201a84f9706
June 24, 2025
2
July 22, 2020
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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
26938327904009 50 06938327904005 2020-07-22 Not in Commercial Distribution carton
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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

[?]
1-614-453-1010
Info@Steriatrics.com
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