FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660173661
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Krause and Beck-Schenck nasal snare replacement wi
Catalog number
84-920
Device description
Krause and Beck-Schenck nasal snare replacement wire, size #0, 0.3mm
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
KBESNARE, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBESnare, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660173661PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660173661001906601736611906601736610190660173661

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
00757770404049Bausch + LombBausch & Lomb IncorporatedKBE2025-07-29
00757770405671Bausch + LombBausch & Lomb IncorporatedKBE2025-07-29
00887482174951Symmetry Surgical®SYMMETRY SURGICAL INC.KBE2024-08-15
00887482192757Symmetry Surgical®SYMMETRY SURGICAL INC.KBE2024-08-15
00887482192764Symmetry Surgical®SYMMETRY SURGICAL INC.KBE2024-08-15
00887482192771Symmetry Surgical®SYMMETRY SURGICAL INC.KBE2024-08-15
G586E7726310Novo SurgicalNOVO SURGICAL, INC.KBE2023-12-18
G586E7726320Novo SurgicalNOVO SURGICAL, INC.KBE2023-12-18
G586E7726330Novo SurgicalNOVO SURGICAL, INC.KBE2023-12-18
G586E97726310Novo SurgicalNOVO SURGICAL, INC.KBE2023-12-18
00842962149355HNM MEDICALHNM STAINLESS, LLC.KBE2023-04-06
00842962149362HNM MEDICALHNM STAINLESS, LLC.KBE2023-04-06
14026704808868PILLINGTELEFLEX INCORPORATEDKBE2022-12-08
54026704808873PILLINGTELEFLEX INCORPORATEDKBE2022-12-08
00842331177804Novo Surgical Inc. NOVO SURGICAL, INC.KBE2022-11-14
00887482042861Symmetry Surgical®SYMMETRY SURGICAL INC.KBE2022-09-30
G043799000BEARBear-Ent, LLCKBE2022-08-02
G043799010BEARBear-Ent, LLCKBE2022-08-02
00190776048624AvalignAVALIGN TECHNOLOGIES, INC.KBE2021-11-03
M36828031GrafcoGF HEALTH PRODUCTS, INC.KBE2021-06-03
M36828051GrafcoGF HEALTH PRODUCTS, INC.KBE2021-06-03
00840113215119Richard-Allan® Nasal SnareASPEN SURGICAL PRODUCTS, INC.KBE2021-02-25
00840113215133Richard-Allan® Nasal SnareASPEN SURGICAL PRODUCTS, INC.KBE2021-02-25
00190660173609Ambler SurgicalAMBLER SURGICAL CORP.KBE2021-01-04
00190660173616Ambler SurgicalAMBLER SURGICAL CORP.KBE2021-01-04
00190660173678Ambler SurgicalAMBLER SURGICAL CORP.KBE2021-01-04
00190660173685Ambler SurgicalAMBLER SURGICAL CORP.KBE2021-01-04
00190660173692Ambler SurgicalAMBLER SURGICAL CORP.KBE2021-01-04
00190660173739Ambler SurgicalAMBLER SURGICAL CORP.KBE2021-01-04
00190660173746Ambler SurgicalAMBLER SURGICAL CORP.KBE2021-01-04