FDA.reportPublic FDA data

Intradermal Needles

Primary DI
50560304000700
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
50560304000700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5056030400070050560304000700

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
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056030400148Anaesthetic Needles0641-03TM06412026-03-04
05056030400155Anaesthetic Needles0641A-03/YM06412026-03-04
05056030400025Anaesthetic Needles0275-03/YM02752024-10-07
25056030401804Bimanual I/A SystemsM5537-02/5M55372025-08-22
25056030400999Refractive CannulaeM2801-02/10 M28012025-03-25
25056030401019Vitreoretinal CannulaeM4449-02/10M44492025-03-25
25056030401484Vitreoretinal HandpiecesM4503-02/5M45032025-03-25
35056030400996Vitreoretinal CannulaeM4447-02/10M44472025-03-25
35056030401009Vitreoretinal CannulaeM4478-02/10M44782025-03-25
55056030400969Hydrodissection CannulaeM3992-02M39922025-02-17
15056030401746Bimanual I/A SystemsM5531-02/5M55312025-01-30
35056030400781Hydrodissection CannulaeM3907-02/10M39072024-12-09
25056030401392Handpieces and CannulaeM4495-02/5M44952024-12-09
15056030400244Anterior Chamber Maintenance CannulaeM2273B-02/10M2273B2024-12-09
15056030400541Formed Irrigating CystotomesM3001-02/10M30012024-12-09
25056030402399Lachrymal CannulaeM9277-02/10M92772024-12-09
35056030401740Bimanual I/A Systems5531NS-02/YM55312024-11-08
25056030403020Handpieces and CannulaeM4504-02/5M45042024-10-18
15056030400534Formed Capsularhexis CystotomesM3000G-02SP/10M3000G2024-10-18
25056030400364Viscoelastic CannulaeM2639A-02/10M2639A2024-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056030400148Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2026-03-04
05056030400155Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2026-03-04
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
10885862658180EXACTECHExactech, Inc.MED2025-11-14
00857635006040Aldahol 1.8ALDEN MEDICAL LLCMED2025-09-12
25056030401804Bimanual I/A SystemsSTERIMEDIX LIMITEDMED2025-08-22
25056030400999Refractive CannulaeSTERIMEDIX LIMITEDMED2025-03-25
25056030401019Vitreoretinal CannulaeSTERIMEDIX LIMITEDMED2025-03-25
25056030401484Vitreoretinal HandpiecesSTERIMEDIX LIMITEDMED2025-03-25
35056030400996Vitreoretinal CannulaeSTERIMEDIX LIMITEDMED2025-03-25
35056030401009Vitreoretinal CannulaeSTERIMEDIX LIMITEDMED2025-03-25
55056030400969Hydrodissection CannulaeSTERIMEDIX LIMITEDMED2025-02-17
15056030401746Bimanual I/A SystemsSTERIMEDIX LIMITEDMED2025-01-30
35056030400781Hydrodissection CannulaeSTERIMEDIX LIMITEDMED2024-12-09
25056030401392Handpieces and CannulaeSTERIMEDIX LIMITEDMED2024-12-09
15056030400244Anterior Chamber Maintenance CannulaeSTERIMEDIX LIMITEDMED2024-12-09
15056030400541Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2024-12-09
25056030402399Lachrymal CannulaeSTERIMEDIX LIMITEDMED2024-12-09
35056030401740Bimanual I/A SystemsSTERIMEDIX LIMITEDMED2024-11-08
25056030403020Handpieces and CannulaeSTERIMEDIX LIMITEDMED2024-10-18
15056030400534Formed Capsularhexis CystotomesSTERIMEDIX LIMITEDMED2024-10-18
25056030400364Viscoelastic CannulaeSTERIMEDIX LIMITEDMED2024-10-18
05056030400025Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2024-10-07
05056030400162Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2024-10-07