FDA.reportPublic FDA data

EXEL 1mL CARRYING AND DELIVERY SYRINGE

Primary DI
00020221017809
Brand
EXEL 1mL CARRYING AND DELIVERY SYRINGE
Company
Exel International
Model
OSTDS1
Catalog number
OSTDS1
Device description
EXEL 1mL CARRYING AND DELIVERY SYRINGE; 10PCS/PK, 10PK/BX, 1000PC/CASE
Published
2023-04-21
Public version status
Update
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
EIDSyringe, Restorative And Impression Material

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10020221017806PackageGS110In Commercial Distribution
20020221017803PackageGS110In Commercial Distribution
30020221017800PackageGS110In Commercial Distribution
00020221017809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002022101780610020221017806
2002022101780320020221017803
3002022101780030020221017800
00020221017809000202210178090202210178090020221017809

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA 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 needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
180572216
Device count
1
DM exempt
false
Premarket exempt
true
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
00020221012156Tandem Diabetes 3mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’100121510012152023-04-17
00020221012163Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’100121610012162023-04-17
000202210605081 mL sterile syringe SNAP26050SNAP26050SNAP2023-04-04
00020221064483EXEL HYPO NDL 28GX3/4" T.W. 2,000/CS, 100PCS/BOX26448B26448B2023-04-06
00020221260175EXEL 0.3mL INS SYR 28GX1/2"26017260172023-03-20
00020221260199EXEL 0.3mL INS SYR 30GX1/2"26019260192023-03-14
00020221260236EXEL 1/2mL INS SYR 28GX1/2"26023260232024-11-25
00020221260243EXEL 1/2mL INS SYR 28GX1/2"26024260242023-03-15
00020221260328EXEL 1/2mL INS 28GX1/2"26032260322023-03-15
00020221260342EXEL 1mL INS 28GX1/2"26034260342023-03-15
00020221260366EXEL U-40 1/2mL INS SYR 29GX1/2"26036260362023-03-15
00020221260373EXEL U-40 1mL INS SYR 29GX1/2"26037260372023-03-15
00020221260380EXEL 1mL AMBER SYR ONLY LUER SLIP W/ TIP CAP26038260382023-03-15
00020221260458EXEL 1ml SYRINGE 26Gx3/8" L-S26045260452023-03-15
00020221260489EXEL Syringes26048260482016-09-20
00020221260519EXEL 1mL TB 21Gx1"-0-DEAD-SPACE26051260512023-03-15
00020221260564EXEL 1ml Syringe 25Gx1" LDS26056260562023-03-15
00020221260571EXEL 1ml Syringe 23Gx1"26057260572023-03-15
00020221260595EXEL 1mL LDS SYR 20G x 1" LUER LOCK26059260592023-03-15
00020221260601EXEL 1mL ALLERGY SYR 27GX1/2", REGULAR BEVEL26060260602023-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10304040194802Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10371347019886Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-12-30
10371347017783Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-11-18
08800017902203DX-MixerDXM CO., LTDEID2025-09-29
08056000372298Dynamic-static Mixing TipsZHERMACK SPAEID2025-03-28
08056000372304Mixing TipsZHERMACK SPAEID2025-03-28
08056000372311Mixing TipsZHERMACK SPAEID2025-03-28
08056000372328Mixing TipsZHERMACK SPAEID2025-03-28
J014656875140IOT white 96Kulzer GmbHEID2024-09-09
J014660007820IOT yellow 96Kulzer GmbHEID2024-09-09
J014660009050BITE REG INTRAORAL TIP CD 96Kulzer GmbHEID2024-09-09
J014660019880Mixing Tip yellow 1:1 48Kulzer GmbHEID2024-09-09
J014660019890Mixing Tip green 1:1 48Kulzer GmbHEID2024-09-09
08800017901923DX-MixerDXM CO., LTDEID2024-06-04
08800017901978DX-MixerDXM CO., LTDEID2024-06-04
08800017902005DX-MixerDXM CO., LTDEID2024-06-04
08800017902029DX-MixerDXM CO., LTDEID2024-06-04
10810339032064SAFE DENTBGSS Company Inc.EID2024-05-01
07615208353730Clinical Accessory (no MD)IVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-10-25
08800017901893Dynamic MixerDXM CO., LTDEID2023-10-25
08800017901879Dynamic MixerDXM CO., LTDEID2023-10-24
08800017901848DX-MixerDXM CO., LTDEID2023-07-31
08800017901657DX-MixerDXM CO., LTDEID2023-07-26
07615208339932CannulaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-03-23
07615208379297CannulaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-03-23
10371347010845Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2023-02-15
10371347008620Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2023-02-10
10371347008637Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2023-02-10