FDA.reportPublic FDA data

TERUMO

Primary DI
34806017507184
Brand
TERUMO
Company
TERUMO (PHILIPPINES) CORPORATION
Model
SS+05L1
Device description
TERUMO Syringes without Needle
Published
2016-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023271000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023271000TERUMO SYRINGE WITH/WITHOUT NEEDLETerumo Medical Corp.2002-12-18FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54806017507188PackageGS112In Commercial Distribution
34806017507184PrimaryGS10
14806017507180Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5480601750718854806017507188
3480601750718434806017507184
1480601750718014806017507180

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringeA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store at extreme temperature and humidity.
Special Storage Condition, Specify00Fragile. Handle with care. Keep dry. Keep away from sunlight. Stacking limit by 4.

Contacts#

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

Regulatory Flags#

DUNS number
718848773
Device count
100
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
34806017510146SURFLOSR-OX1451CA2016-09-14
34806017510153SURFLOSR-OX1632CA2016-09-14
34806017510160SURFLOSR-OX1651CA2016-09-14
34806017510177SURFLOSR-OX1664CA2016-09-14
34806017510184SURFLOSR-OX1851CA2016-09-14
34806017510191SURFLOSR-OX1864CA2016-09-14
34806017512225SURFLOSR-OX1464CA2016-09-14
34806017512232SURFLOSR-OX1832CA2016-09-14
34806017512249SURFLOSR-OX2051CA2016-09-14
34806017512256SURFLOSR-OX2032CA2016-09-14
34806017512263SURFLOSR-OX2025CA2016-09-14
34806017512270SURFLOSR-OX2225CA2016-09-14
34806017512287SURFLOSR-OX2419CA2016-09-14
14806017506992SURGUARD2SG2+18252017-02-06
14806017507005SURGUARD2SG2+18382017-02-28
14806017507012SURGUARD2SG2+19252017-02-28
14806017507029SURGUARD2SG2+19382017-02-28
14806017507036SURGUARD2SG2+20252017-02-28
14806017507043SURGUARD2SG2+20382017-02-28
14806017507050SURGUARD2SG2+21252017-02-28

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09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
10304040193843Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
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10304040194284Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194291Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194307Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194314Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
05391530753982polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-10-01