FDA.reportPublic FDA data

Intradermal Needles

Primary DI
05056030400070
Brand
Intradermal Needles
Company
STERIMEDIX LIMITED
Model
0287-03/Y
Catalog number
M0287
Device description
30g TW x 12.7mm Long Hypo
Published
2024-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
05056030400070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056030400070050560304000705056030400070

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
504799313
Device count
1
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
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
25056030400999Vitreoretinal CannulaeM4447-02/10M44472025-03-25

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