FDA.reportPublic FDA data

Arthrex®

Primary DI
10888867001968
Brand
Arthrex®
Company
ARTHREX, INC.
Model
ABS-10050
Catalog number
ABS-10050
Device description
VISCOUS-GEL APLICTR W/10CM MIXING TIP
Published
2017-02-15
Public version status
Update
Distribution status
Not 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
FMFSyringe, piston
KYZSYRINGE, IRRIGATING (NON DENTAL)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
KYZSyringe, Irrigating (Non Dental)General Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012868000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012868000MICROMEDICS FIBRIJET AEROSOL APPLICATORMicromedics, Inc.2001-10-29FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888867001968PrimaryGS10
M150ABS100501SecondaryHIBCC0
00888867001961Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886700196810888867001968
00888867001961008888670019618888670019610888867001961

GMDN Terms#

Term, Definition table
TermDefinition
Irrigation syringeA general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
Device count
5
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867023987Arthrex®AR-1934BFT-2AR-1934BFT-22019-03-09
00888867050372Arthrex®AR-8934BNFAR-8934BNF2018-12-13
00888867290778Arthrex®AR-1938PSSAR-1938PSS2018-04-19
00888867348691Arthrex®AR-1934BCT-2AR-1934BCT-22022-07-11
00888867375116Arthrex®AR-8934BCSTAR-8934BCST2021-05-24
00888867375123Arthrex®AR-8934BCST-2AR-8934BCST-22021-05-24
00888867443624Arthrex®AR-2424PHSAR-2424PHS2024-01-25
00888867443631Arthrex®AR-2424PHS-1AR-2424PHS-12024-01-25
00888867384811Arthrex®AR-8934BCST-1AR-8934BCST-12021-05-24
00888867384828Arthrex®AR-8934BCST-2-1AR-8934BCST-2-12021-05-24
00888867285057Arthrex®AR-1934PF-24-1AR-1934PF-24-12020-12-15
00888867293830Arthrex®AR-1938PSS-1AR-1938PSS-12018-10-29
00888867335035Arthrex®AR-2923BCSAR-2923BCS2020-03-16
00888867088306Arthrex®AR-13110R-02AR-13110R-022017-02-15
00888867046641Arthrex®AR-8825BAR-8825B2017-02-15
00888867046672Arthrex®AR-8825PAR-8825P2017-02-15
00888867131491Arthrex®AR-8923BCAR-8923BC2017-02-15
00888867022874Arthrex®AR-1922BCAR-1922BC2017-02-15
00888867022959Arthrex®AR-1922PSAR-1922PS2017-02-15
00888867023017Arthrex®AR-1923BCAR-1923BC2017-02-15

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Primary DI, Brand, Company table
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00850091070426CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
06976523540238Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540245Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540252Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
10841767195717Trinity Sterile, Inc.Trinity Sterile, Inc.KYZ2026-08-25
00193982458119INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14
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00193982504403INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14
00884450487402Merit Medical®Merit Medical Systems, Inc.FMF2026-08-07
08800045103061Feel Ject(FIS-054, U-100, 1.0cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105164Feel Ject(FIS-202, U-100, 0.3 cc, 29G x 12.7mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105256Feel Ject(FIS-205, U-100, 0.3 cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105492Feel Ject(FIS-213, U-100, 1.0cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105614Feel Ject(FIS-217, U-100, 0.5 cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
00810131885045ION Non CervicalSurgentec, LLCFMF2026-07-28
00884450486955Merit Medical®Merit Medical Systems, Inc.FMF2026-07-25
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
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