FDA.reportPublic FDA data

Intradermal Cannulae and Needles

Primary DI
25056030402733
Brand
Intradermal Cannulae and Needles
Company
STERIMEDIX LIMITED
Model
AJ1861A-02/40
Catalog number
AJ1861A
Device description
Silkann(FT) Cann 27gx40mm
Published
2024-10-07
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
MEDSterilant, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEDSterilant, Medical DevicesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25056030402733PrimaryGS10
15056030402736Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2505603040273325056030402733
1505603040273615056030402736

GMDN Terms#

Term, Definition table
TermDefinition
Tissue injection cannulaA thin, sterile, semi-rigid or rigid metal tube intended to be inserted percutaneously for the injection of a substance into the cutaneous or subcutaneous layers. It is typically used for the administration of fillers [e.g., hyaluronic acid (HA)] to add volume to tissue for cosmetic or reconstructive purposes. The device is typically designed with a closed-off nose and a lateral hole at the distal tip, and a connector at the proximal end for attachment to a device that propels the injection substance. It is typically made of high-grade stainless steel. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
504799313
Device count
40
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056030400148Anaesthetic Needles0641-03TM06412026-03-04
05056030400155Anaesthetic Needles0641A-03/YM06412026-03-04
25056030400548Formed Irrigating CystotomesM3001-02/10M30012024-12-09
05056030400025Anaesthetic Needles0275-03/YM02752024-10-07
05056030402821Formed Irrigating Cystotomes3628A-03/YM3628A2024-10-07
25056030404089Anterior Cannula2825-02M28252026-02-24
05056030400070Intradermal Needles0287-03/YM02872024-10-07
05056030400124Anaesthetic Needles0639-03/YM06392024-10-07
05056030400179Anaesthetic Needles0642A-03/YM0642A2024-10-07
05056030400520Formed Capsularhexis Cystotomes3000F-03/YM3000F2024-10-07
05056030400674Formed Irrigating Cystotomes3629-03/YM36292024-10-07
65056030402922Vitreoretinal CannulaeM4486-02/100M44862025-10-27
35056030400842Anterior Chamber Maintenance CannulaeM2279-02/100 M22792025-10-10
45056030400139Anaesthetic NeedlesM0638-02/100M06382025-10-06
15056030401807Bimanual I/A SystemsM5537-02/5M55372025-08-22
45056030400122Anaesthetic NeedlesM0637-02/100M06372025-08-22
25056030401804Bimanual I/A SystemsM5537-02/5M55372025-08-22
15056030401012Vitreoretinal CannulaeM4449-02/10M44492025-03-25
15056030401487Vitreoretinal HandpiecesM4503-02/5M45032025-03-25
25056030401316Vitreoretinal CannulaeM4478-02/10M44782025-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056030400148Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2026-03-04
05056030400155Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2026-03-04
25056030404089Anterior CannulaSTERIMEDIX LIMITEDMED2026-02-24
10705037048755AEROZYME™ XTRAADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041480CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041510CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041596CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041602CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041664CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
20705037048752AEROZYME™ XTRAADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10885862658159EXACTECHExactech, Inc.MED2025-11-14
10885862658166EXACTECHExactech, Inc.MED2025-11-14
10885862658173EXACTECHExactech, Inc.MED2025-11-14
10885862658180EXACTECHExactech, Inc.MED2025-11-14
10885862658197EXACTECHExactech, Inc.MED2025-11-14
10885862658203EXACTECHExactech, Inc.MED2025-11-14
10885862658210EXACTECHExactech, Inc.MED2025-11-14
10885862658227EXACTECHExactech, Inc.MED2025-11-14
10885862658234EXACTECHExactech, Inc.MED2025-11-14
65056030402922Vitreoretinal CannulaeSTERIMEDIX LIMITEDMED2025-10-27
35056030400842Anterior Chamber Maintenance CannulaeSTERIMEDIX LIMITEDMED2025-10-10
45056030400139Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2025-10-06
00857635006040Aldahol 1.8ALDEN MEDICAL LLCMED2025-09-12
15056030401807Bimanual I/A SystemsSTERIMEDIX LIMITEDMED2025-08-22
45056030400122Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2025-08-22
25056030401804Bimanual I/A SystemsSTERIMEDIX LIMITEDMED2025-08-22
15056030401012Vitreoretinal CannulaeSTERIMEDIX LIMITEDMED2025-03-25
15056030401487Vitreoretinal HandpiecesSTERIMEDIX LIMITEDMED2025-03-25
25056030401316Vitreoretinal CannulaeSTERIMEDIX LIMITEDMED2025-03-25
15056030400961Hydrodissection CannulaeSTERIMEDIX LIMITEDMED2025-02-17