Comfort EZ

Primary DI
20850083784328
Brand
Comfort EZ
Company
S.D.I. USA, INC.
Model
SSTB25G1ML58
Device description
Safety Tuberculin 25G 5/8 in. 1 mL Syringe Hinged Safety Needle Ultra Thin Wall (Exchangeable Needle) 100/bx 6bx/cs
Published
2026-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEGSyringe, AntistickGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850083784324PrimaryGS10
20850083784328Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850083784324008500837843248500837843240850083784324
2085008378432820850083784328

GMDN Terms#

Term, Definition table
TermDefinition
Tuberculin/allergy syringe/needle, safetyA sterile device consisting of a calibrated barrel (cylinder) with plunger, with an attached needle (sometimes shielded), intended to be used to administer a precise, low-dosage injection of tuberculin and/or sensitivity test allergen to a patient subcutaneously. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patients. After use, the needle can be fully retracted into the barrel, providing protection against needle sticks and rendering the device unusable. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.625Inch
Needle Gauge25Gauge
Total Volume1Milliliter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116722847
Device count
100
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850083784003Comfort EZLL12026-02-13
00850083784041Comfort EZLL1INS2026-02-13
00850083784058Comfort EZHYP18G12026-02-13
00850083784171Comfort EZHYP25G1S2026-02-13
00850083784270Comfort EZSS23G3ML12026-02-13
00850083784324Comfort EZSSTB25G1ML582026-02-13
00850083784348Comfort EZNS18G3ML1.52026-02-13
00850083784409Comfort EZBLN18G1.52026-02-13
20850083784007Comfort EZLL12026-02-13
20850083784045Comfort EZLL1INS2026-02-13
20850083784052Comfort EZHYP18G12026-02-13
20850083784175Comfort EZHYP25G1S2026-02-13
20850083784274Comfort EZSS23G3ML12026-02-13
20850083784342Comfort EZNS18G3ML1.52026-02-13
20850083784403Comfort EZBLN18G1.52026-02-13
00850002860702Comfort EZ ProSPN-30G850002-0860-702023-08-01
00850002860719Comfort EZ ProSPN-31G550002-0860-712023-08-01
00850002860726Comfort EZ ProSPN-31G450002-0860-722023-08-01
10850002860709Comfort EZ ProSPN-30G850002-0860-702023-08-01
10850002860716Comfort EZ ProSPN-31G550002-0860-712023-08-01

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Primary DI, Brand, Company table
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10840330705568ProCureTwin Med, LLCMEG2026-05-27
08800052609204"SHINA SAFETY SYRINGE 1.0cc 23G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609211"SHINA SAFETY SYRINGE 1.0cc 25G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609228"SHINA SAFETY SYRINGE 3.0cc 23G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609235"SHINA SAFETY SYRINGE 3.0cc 25G x 1"""SHINA MED CORPORATIONMEG2026-03-25
09347144013093Metier MedicalMETIER MEDICAL LTDMEG2025-07-08
10850053289627SURGYCOSurgyco LLCMEG2024-08-09
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10850053289665SURGYCOSurgyco LLCMEG2024-08-09
10885380184703MonojectCardinal Health 200, LLCMEG2024-03-26
10885380184987MonojectCardinal Health 200, LLCMEG2024-03-26
10885380184994MonojectCardinal Health 200, LLCMEG2024-03-26
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10193489037944MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037951MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10