FDA.reportPublic FDA data

BD Safe-Clip

Primary DI
50382903282352
Brand
BD Safe-Clip
Company
Becton, Dickinson and Company Inc
Model
328235
Catalog number
328235
Device description
SAFE-CLIP
Published
2016-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, hypodermic, single lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943683000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943683000B-D SAFE-CLIPBecton Dickinson Consumer Products1994-10-31FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903282352PackageGS112In Commercial Distribution
00382903282357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290328235250382903282352
00382903282357003829032823573829032823570382903282357

GMDN Terms#

Term, Definition table
TermDefinition
Needle cutterA device designed to cut a syringe needle to prevent its reuse. It typically includes a sharp metal cutting blade housed in a plastic container that receives the pieces of the destroyed needle. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047047543
Device count
1
DM exempt
true
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382903234875BD Home Sharps Collector3234873234872016-08-03
30382903249061BD Veo3249063249062018-02-23
30382903249078BD Veo3249073249072018-02-23
30382903249085BD Veo3249083249082018-02-23
30382903282785BD Ultra-Fine3282783282782016-08-03
30382903282792BD Ultra-Fine3282793282792016-08-03
30382903282808BD Ultra-Fine3282803282802016-08-03
30382903282891BD Ultra-Fine3282893282892016-08-03
30382903282907BD Ultra-Fine3282903282902016-08-03
30382903282914BD Ultra-Fine3282913282912016-08-03
30382903294108BD Micro-Fine3294103294102016-08-03
30382903294122BD Micro-Fine3294123294122016-08-03
30382903294207BD Micro-Fine3294203294202016-08-03
30382903294245BD Micro-Fine3294243294242016-08-03
30382903294610BD Micro-Fine3294613294612016-08-03
30382903294658BD Micro-Fine3294653294652016-08-03
00382903249091BD Veo3249093249092018-02-23
00382903249107BD Veo3249103249102018-02-23
00382903249114BD Veo3249113249112018-02-23
00382903249121BD Veo3249123249122018-02-23

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Primary DI, Brand, Company table
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00050428167243TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
00050428167267TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
06958697621821One+Step INSULIN PEN NEEDLEANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTDFMI2026-10-01
M99230402912120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
M99230403250120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
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16972857299252Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-09-24
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MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
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00850091070334CoreCareCORECARE PRODUCTS INC.FMI2026-09-04