FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660121280
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Hough needle
Catalog number
57-120
Device description
Hough needle, 5 7/8'', straight shaft, straight pointed tip, hexagonal handle
Published
2021-01-07
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KBRNEEDLE, TONSIL SUTURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBRNeedle, Tonsil SuturingEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660121280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660121280001906601212801906601212800190660121280

GMDN Terms#

Term, Definition table
TermDefinition
Exploratory blunt needle, reusableA slender hand-held manual instrument designed with a dull curved tip intended to prevent damage to sensitive and delicate tissues while it is being used to explore within the body. 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
00194613021894MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-08-01
00194613046040MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-08-01
00194613112448MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-08-01
00194613115449MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-08-01
00194613109752MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-03-21
00190776388744MillenniumAvalign Technologies, Inc.KBR2024-11-14
00887482173800Symmetry Surgical®SYMMETRY SURGICAL INC.KBR2024-08-15
00887482046562Symmetry Surgical®SYMMETRY SURGICAL INC.KBR2024-08-01
00887482119167Symmetry Surgical®SYMMETRY SURGICAL INC.KBR2024-08-01
00887482119174Symmetry Surgical®SYMMETRY SURGICAL INC.KBR2024-08-01
00887482123966Symmetry Surgical®SYMMETRY SURGICAL INC.KBR2024-08-01
00887482123973Symmetry Surgical®SYMMETRY SURGICAL INC.KBR2024-08-01
00840343722203GEN2SURGIX MEDICAL LLCKBR2024-04-23
G586E8306200Novo SurgicalNOVO SURGICAL, INC.KBR2023-12-18
00840343720414GEN2SURGIX MEDICAL LLCKBR2023-12-08
00190776303990MillenniumAvalign Technologies, Inc.KBR2023-11-16
00190776304904MillenniumAvalign Technologies, Inc.KBR2023-11-16
00190776044077AvalignAvalign Technologies, Inc.KBR2023-09-28
00190776290733MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776319625MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776319700MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776319885MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776322281MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776322298MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776373801MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776378264MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00840343716240GEN2SURGIX MEDICAL LLCKBR2023-03-22
54026704805025PILLINGTELEFLEX INCORPORATEDKBR2022-12-08
54026704805032PILLINGTELEFLEX INCORPORATEDKBR2022-12-08
54026704805346PILLINGTELEFLEX INCORPORATEDKBR2022-12-08