AccessGUDID - DEVICE: SURGUARD3 (34806017508488)

GUDID

Device Identifier (DI) Information

Brand Name: SURGUARD3
Version or Model: SG3-03L2138
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TERUMO (PHILIPPINES) CORPORATION

Primary DI Number: 34806017508488
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 718848773 *Terms of Use

Device Description: SURGUARD3 Hypodermic Syringe with Safety Needle

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35904	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEG	SYRINGE, ANTISTICK

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113422	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Fragile. Handle with care. Keep dry. Keep away from sunlight. Stacking limit by 3.

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: df0737f2-a8c1-4bb2-a725-0dea705c032e
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 07, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
54806017508482	4	34806017508488		In Commercial Distribution	Carton

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 14806017508484 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)283-7866
Email: tmccustomer.admin@terumomedical.com

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