FDA.reportPublic FDA data

Ceros

Primary DI
10850041572441
Brand
Ceros
Company
Rhino Medical Supply Inc
Model
RM-SN121815
Catalog number
RM-SN121815
Device description
Ceros Safety Hypodermic Needle, 18 G x 1 1/2", Pink Hub, Latex Free, DEHP Free, PVC Free
Published
2026-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193526000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193526000Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd2020-07-17FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850041572441PackageGS1100In Commercial Distribution
20850041572448PackageGS18In Commercial Distribution
00850041572444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004157244110850041572441
2085004157244820850041572448
00850041572444008500415724448500415724440850041572444

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.5Inch
Needle Gauge18Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
833-997-4466info@rhinomedicalsupply.com

Regulatory Flags#

DUNS number
117524559
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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
00810192690084CerosRM-PF1205RM-PF12052025-11-18

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