FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660173715
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Krause ear snare replacement wire
Catalog number
84-402
Device description
Krause ear snare replacement wire, package of 12
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
JZDSNARE, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZDSnare, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660173715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660173715001906601737151906601737150190660173715

GMDN Terms#

Term, Definition table
TermDefinition
Nasal snare, reusableA hand-held manual surgical instrument intended to be inserted into the naris for the removal of tissue, typically polyps, tumours, and other abnormal tissue from the nasal cavity during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the tissue to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). 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
true
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
00757770412914Bausch + LombBausch & Lomb IncorporatedJZD2025-08-04
00842962145937HNM MedicalHNM STAINLESS, LLC.JZD2024-03-08
00888515231061BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JZD2024-02-28
00888515231085BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JZD2024-02-28
00190776221171AvalignAVALIGN TECHNOLOGIES, INC.JZD2023-06-23
00842331189456Novo Surgical Inc. NOVO SURGICAL, INC.JZD2022-11-14
00190660173708Ambler SurgicalAMBLER SURGICAL CORP.JZD2021-01-04
00190660173722Ambler SurgicalAMBLER SURGICAL CORP.JZD2021-01-04
04046826102258MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826317539MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826102241MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826317522MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826317546MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826276126MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826276140MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826276157MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
B351B699000BEARMytamed, Inc.JZD2020-08-20
B351B699010BEARMytamed, Inc.JZD2020-07-13
04038653176342AESCULAPAesculap AGJZD2020-04-22
04038653341269AESCULAPAesculap AGJZD2020-04-22
00888118057716SNAREKLS-Martin L.P.JZD2018-09-26
00888118057723SNAREKLS-Martin L.P.JZD2018-09-26
70885403111732V. MuellerCAREFUSION 2200, INCJZD2018-09-14
70885403111756V. MuellerCAREFUSION 2200, INCJZD2018-09-14
70885403111749V. MuellerCAREFUSION 2200, INCJZD2018-09-14
70885403111763V. MuellerCAREFUSION 2200, INCJZD2018-09-14
10885403008917V. MuellerCAREFUSION 2200, INCJZD2018-08-02
70885403160525V. MuellerCAREFUSION 2200, INCJZD2018-08-02
M2743801751Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZD2018-03-02
B351699010mytaMedMytamed, Inc.JZD2018-02-16