FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660109745
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Wright fascia needle
Catalog number
5264E
Device description
Wright fascia needle, 5 1/8'', curved shaft, 2.0mm wide tip and 1.0mm x 6.0mm eye, ring handle
Published
2021-01-04
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDMNEEDLE, ASPIRATION AND INJECTION, REUSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDMNeedle, Aspiration And Injection, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660109745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660109745001906601097451906601097450190660109745

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid fascia-introduction needleA hand-held manual surgical instrument intended for the introduction of autologous fascia, or synthetic material, into the upper eyelid during a temporalis sling operation for the treatment of ptosis. Otherwise known as Wright’s fascia needle, it has a very slender tip with an eyelet to hold the material being pulled through the eyelid. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags#

DUNS number
015272206
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
false
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
00190660029340Ambler SurgicalThornton triple vertical and 15 degree cutting edg21-328E2021-01-18
00190660000509Ambler SurgicalTendon approximator43-1602021-01-07
00190660002121Ambler SurgicalAir injection cannula1022E2021-01-07
00190660002138Ambler SurgicalAir injection cannula1328E2021-01-07
00190660002145Ambler SurgicalAir injection cannula1023E2021-01-07
00190660002152Ambler SurgicalAir injection cannula1031E2021-01-07
00190660002169Ambler SurgicalAir injection cannula1329E2021-01-07
00190660002176Ambler SurgicalAir injection cannula1026E2021-01-07
00190660002183Ambler SurgicalAir injection cannula1024E2021-01-07
00190660002190Ambler SurgicalAir injection cannula1028E2021-01-07
00190660002206Ambler SurgicalAir injection cannula1029E2021-01-07
00190660002213Ambler SurgicalAir injection cannula1027E2021-01-07
00190660002237Ambler SurgicalAir injection cannula1327E2021-01-07
00190660002244Ambler SurgicalAir injection cannula1030E2021-01-07
00190660002268Ambler SurgicalAir injection cannula1330E2021-01-07
00190660002329Ambler SurgicalAlio LASIK irrigation cannula5193E2021-01-07
00190660002343Ambler SurgicalAnis cortex aspirating cannula1429E2021-01-07
00190660002350Ambler SurgicalAnis cortex aspirating cannula1097E2021-01-07
00190660002824Ambler SurgicalBinkhorst irrigating cannula1332E2021-01-07
00190660002831Ambler SurgicalBinkhorst irrigating cannula1333E2021-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24026704934595PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
24026704934601PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
24026704934618PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
D928106122R450SUCTION TIP #2-REGULAR - 45DEG RIGHT GRIND ANGLEW.H. Holden, Inc.GDM2026-01-15
04059453120823Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDM2025-12-05
04059453124135Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDM2025-08-25
00810130455386Medco ManufacturingMedco Manufacturing LLCGDM2025-08-07
00810130455393Medco ManufacturingMedco Manufacturing LLCGDM2025-08-07
00194613120238MSI Precision Specialty InstrumentsMed Saver, Inc.GDM2025-08-01
00810130455300Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455317Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455324Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455331Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455218Medco ManufacturingMedco Manufacturing LLCGDM2025-06-27
00810130455225Medco ManufacturingMedco Manufacturing LLCGDM2025-06-27
00810130455232Medco ManufacturingMedco Manufacturing LLCGDM2025-06-27
00810130455164Medco ManufacturingMedco Manufacturing LLCGDM2025-06-17
00810130455140Medco ManufacturingMedco Manufacturing LLCGDM2025-06-10
00190776401139MillenniumAvalign Technologies, Inc.GDM2025-06-09
D92810613410SUCTION TIP THREADED #4 W/ HOLEW.H. Holden, Inc.GDM2025-05-21
00810130455003Medco ManufacturingMedco Manufacturing LLCGDM2025-05-06
00192896121492Heparin Olive Tip Needle CannulaSONTEC INSTRUMENTS, INC.GDM2025-04-22
00810130454976Medco ManufacturingMedco Manufacturing LLCGDM2025-04-04
00810130454907Medco ManufacturingMedco Manufacturing LLCGDM2025-03-27
00840516142685Anodyne SurgicalPsi/Eye-Ko, Inc.GDM2025-02-28
00819127023515Tulip Medical Products Reusable CannulasTulip Medical ProductsGDM2025-02-05
00810130454662Medco ManufacturingMedco Manufacturing LLCGDM2024-12-19
00810130454631Medco ManufacturingMedco Manufacturing LLCGDM2024-12-18
D928106121D450SUCTION TIP #1 REGULAR, 9 IN. LENGTH, 1MM, 45 DEGREE DOWN GRINDW.H. Holden, Inc.GDM2024-12-18
D928106121HV20SUCTION TIP #1 HI VOLUME B-STYLE, 9 IN. LENGTH, 1MMW.H. Holden, Inc.GDM2024-12-18