FDA.reportPublic FDA data

SurgyNeedle

Primary DI
00810014630243
Brand
SurgyNeedle
Company
U.S. SURGITECH INC.
Model
780-416
Published
2020-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00810014630250PackageGS110In Commercial Distribution
00810014630267PackageGS1100In Commercial Distribution
00810014630243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810014630250008100146302508100146302500810014630250
00810014630267008100146302678100146302670810014630267
00810014630243008100146302438100146302430810014630243

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.

Regulatory Flags#

DUNS number
142007082
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

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