FDA.reportPublic FDA data

Anaesthetic Needles

Primary DI
50560304001240
Brand
Anaesthetic Needles
Company
STERIMEDIX LIMITED
Model
0639-03/Y
Catalog number
M0639
Device description
23g x 1 1/2" Retrobulbar
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
50560304001240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5056030400124050560304001240

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic needle, single-useA slender, straight hollow instrument, usually with a sharp bevelled end, designed to be used with a syringe for the transient delivery of fluid materials (e.g., anaesthetic agents, therapeutic drugs) to various structures in and around the eye, including the eye muscles, or to an intraocular implant; it may also be intended for aspiration (e.g., aqueous humour). It is made of metal and/or plastic materials and may include a needle positioning and perforation depth guide. 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
true
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
15056030400688Formed Irrigating Cystotomes02SP/10M3629A2026-06-24
25056030403785Formed Irrigating Cystotomes02SP/10M36022026-06-24
25056030403792Formed Irrigating Cystotomes02SP/10M3626A2026-06-24
25056030403808Formed Irrigating Cystotomes02SP/10M36272026-06-24
25056030403815Formed Irrigating Cystotomes02SP/10M3627A2026-06-24
25056030403822Formed Irrigating Cystotomes02SP/10M36302026-06-24
25056030403839Formed Irrigating Cystotomes02SP/10M36292026-06-24
25056030403846Formed Irrigating Cystotomes02SP/10M3615A2026-06-24
25056030403853Formed Irrigating Cystotomes02SP/10M36152026-06-24
25056030403860Formed Irrigating Cystotomes02SP/10M3610S2026-06-24
25056030403877Formed Irrigating Cystotomes02SP/10M3610C2026-06-24
25056030403884Formed Irrigating Cystotomes02SP/10M3000E2026-06-24
25056030403891Formed Irrigating Cystotomes02SP/10M36102026-06-24
25056030403907Formed Irrigating Cystotomes02SP/10M3610B2026-06-24
25056030403914Formed Irrigating Cystotomes02SP/10M3000D2026-06-24
25056030403921Formed Irrigating Cystotomes02SP/10M3000F2026-06-24
25056030403938Formed Irrigating Cystotomes02SP/10M3000G2026-06-24
25056030403945Formed Irrigating Cystotomes02SP/10M30012026-06-24
25056030403952Formed Irrigating Cystotomes02SP/10M36262026-06-24
05056030400148Anaesthetic Needles0641-03TM06412026-03-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15056030400688Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403785Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403792Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403808Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403815Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403822Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403839Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403846Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403853Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403860Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403877Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403884Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403891Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403907Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403914Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403921Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
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