DEVICE: SURGUARD3 (14806017509283)

Device Identifier (DI) Information

SURGUARD3
SG3+03L2138
In Commercial Distribution

TERUMO (PHILIPPINES) CORPORATION
14806017509283
GS1

1
718848773 *Terms of Use
SURGUARD3 Hypodermic Syringe with Safety Needle
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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
Metered-delivery hypodermic syringe A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
MEG SYRINGE, ANTISTICK
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Fragile. Handle with care. Keep dry. Keep away from sunlight. Stacking limit by 4.
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Clinically Relevant Size

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Size Type Text
Needle Gauge: 21 Gauge
Total Volume: 3 Milliliter
Length: 1.5 Inch
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Device Record Status

baf6a1b8-01e1-4d05-b2ec-3fca7c03578e
March 29, 2018
2
February 06, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
54806017509281 4 34806017509287 In Commercial Distribution Carton
34806017509287 100 14806017509283 In Commercial Distribution Shelfbox
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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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
No
No CLOSE

Customer Contact

[?]
+1(800)283-7866
tmccustomer.admin@terumomedical.com
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