FDA.reportPublic FDA data

Ceros

Primary DI
00850041572765
Brand
Ceros
Company
Rhino Medical Supply Inc
Model
RM-SN0112805TB
Catalog number
RM-SN0112805TB
Device description
"Ceros Tuberculin Needle & Syringe, 1 mL, 28 G x 1/2"", Gray Polypropylene Hub, Latex Free, DEHP Free, PVC Free "
Published
2024-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192551000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192551000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850041572762PackageGS1100In Commercial Distribution
20850041572769PackageGS18In Commercial Distribution
00850041572765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004157276210850041572762
2085004157276920850041572769
00850041572765008500415727658500415727650850041572765

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.5Inch
Needle Gauge28Gauge
Total Volume1Milliliter

Regulatory Flags#

DUNS number
117524559
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850060997983CerosRM-SN122705RM-SN1227052026-02-23
10850060997980CerosRM-SN122705RM-SN1227052026-02-23
00850041572444CerosRM-SN121815RM-SN1218152026-01-27
00850041572536CerosRM-SN122310RM-SN1223102026-01-27
00850060997952CerosRM-SN122510RM-SN1225102026-01-27
00850060997969CerosRM-SN122515RM-SN1225152026-01-27
00850060997976CerosRM-SN122558RM-SN1225582026-01-27
10850041572441CerosRM-SN121815RM-SN1218152026-01-27
10850041572533CerosRM-SN122310RM-SN1223102026-01-27
10850060997959CerosRM-SN122510RM-SN1225102026-01-27
10850060997966CerosRM-SN122515RM-SN1225152026-01-27
10850060997973CerosRM-SN122558RM-SN1225582026-01-27
00850060997440CerosRM-SN15BRM-SN15B2024-03-18
00850060997457CerosRM-SN15DRM-SN15D2024-03-19
00850060997464CerosRM-SN15ERM-SN15E2024-03-19
00850060997433CerosRM-SN15ARM-SN15A2024-03-18
00810192690114CerosRM-PF1203RM-PF12032025-11-18
00810192690619CerosRM-PF1210SFRM-PF1210SF2025-11-18
00810192690701CerosRM-CST1410RM-CST14102025-11-18
00810192690053CerosRM-PF1210RM-PF12102025-11-18

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