FDA.reportPublic FDA data

SurgyNeedle

Primary DI
00810014635101
Brand
SurgyNeedle
Company
U.S. SURGITECH INC.
Model
780-411
Catalog number
780-411
Device description
5mm disposable aspiration needle, 15ga needle, 40cm length
Published
2019-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAANeedle, Aspiration And Injection, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810014635095PackageGS110In Commercial Distribution
00810014635101PackageGS1100In Commercial Distribution
00810014635088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810014635095008100146350958100146350950810014635095
00810014635101008100146351018100146351010810014635101
00810014635088008100146350888100146350880810014635088

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
142007082
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
00810014639901SurgyCut790SCBF012024-10-10
00810014636832SurgyPad780SP92024-10-10
10810014639908SurgyCut790SCBF012024-10-10
00810014639918SurgyCut790SCGF12024-10-10
00810014631820SurgyCut790-200-535790-200-5352019-03-05
00810014631851SurgyCut790-201-535790-201-5352019-03-20
00810014631882SurgyCut790-202-535790-202-5352019-03-05
00810014631912SurgyCut790-203-535790-203-5352019-03-20
00810014631943SurgyCut790-204-5352019-09-17
00810014632841SurgyCut790-200-5452023-06-09
00810014631974SurgyCut790-205-5352019-12-03
00810014632872SurgyCut790-201-5452019-10-22
00810014635736SurgyFoam780SP12023-07-31
00810014632575SurgyCut790-119-5452023-06-14
00810014632605SurgyCut790-120-5452023-06-14
00810014632582SurgyCut790-119-5452023-06-14
00810014632612SurgyCut790-120-5452023-06-14
00810014632155SurgyCut790-105-5452023-06-09
00810014632186SurgyCut790-106-5452023-06-09
00810014632216SurgyCut790-107-5452023-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253057461TurkelCardinal Health 200, LLCGAA2026-05-13
08800176593120WHITEROSE MICRO CANNULAUC MedicalGAA2026-04-07
10192253025262MonojectCardinal Health 200, LLCGAA2026-01-16
10192253025125MonojectCardinal Health 200, LLCGAA2026-01-12
08800176593069WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593076WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593083WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176592949WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592956WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592963WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592970WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592987WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592994WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592390WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592406WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592413WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592420WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592444WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592451WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592468WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592475WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592499WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592505WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592512WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592529WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592536WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592543WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592550WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592567WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592598WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08