FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660000097
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Daniels tonsillectome
Catalog number
10-104
Device description
Daniels tonsillectome, size #3, 26.0mm wide blade
Published
2021-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCATONSILLECTOME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCATonsillectomeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660000097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660000097001906600000971906600000970190660000097

GMDN Terms#

Term, Definition table
TermDefinition
TonsillectomeA hand-held manual surgical instrument designed to remove tonsils during a toncillectomy. It can be designed as either a flexible loop for grasping and holding the tonsil or a metal frame which holds and guides a sliding knife blade (a guillotine). The loop type holds the tonsil so it may be surgically cut with a knife. The frame type has a variety of designs of manual cranks that operate the sliding knife blade which cuts off the tonsil. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190660083373Ambler SurgicalAmbler ingrown tissue hook37-1292021-01-07
00190660086343Ambler SurgicalR-Style nerve hook37-8252021-01-07
00190660086350Ambler SurgicalR-Style nerve hook37-8272021-01-07
00190660086367Ambler SurgicalR-Style nerve hook37-8262021-01-07
00190660086374Ambler SurgicalR-Style nerve hook37-8282021-01-07
00190660086381Ambler SurgicalYasargil micro hook37-8722021-01-07
00190660086398Ambler SurgicalYasargil micro hook37-8702021-01-07
00190660121549Ambler SurgicalR-Style needle57-4262021-01-07
00190660121556Ambler SurgicalR-Style needle57-4282021-01-07
00190660141578Ambler SurgicalSalinger reduction instrument73-1252021-01-07
00190660100360Ambler SurgicalFiberoptic light cable40-8002021-01-04
00190660100377Ambler SurgicalFiberoptic light cable40-5002021-01-04
00190660100384Ambler SurgicalFiberoptic light cable40-8102021-01-04
00190660100391Ambler SurgicalFiberoptic light cable40-5052021-01-04
00190660100407Ambler SurgicalFiberoptic light cable40-8202021-01-04
00190660100414Ambler SurgicalFiberoptic light cable40-8302021-01-04
00190660100421Ambler SurgicalFiberoptic light cable40-5102021-01-04
00190660100438Ambler SurgicalFiberoptic light cable40-5152021-01-04
00190660100445Ambler SurgicalFiberoptic light cable40-5202021-01-04
00190660100452Ambler SurgicalFiberoptic light cable40-5252021-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776228095AvalignAvalign Technologies, Inc.KCA2023-06-23
00190660000042Ambler SurgicalAMBLER SURGICAL CORP.KCA2021-01-04
00190660000059Ambler SurgicalAMBLER SURGICAL CORP.KCA2021-01-04
00190660000066Ambler SurgicalAMBLER SURGICAL CORP.KCA2021-01-04
00190660000073Ambler SurgicalAMBLER SURGICAL CORP.KCA2021-01-04
00190660000080Ambler SurgicalAMBLER SURGICAL CORP.KCA2021-01-04
M6334164410JEDMEDJEDMED INSTRUMENT COMPANYKCA2020-09-01
M63341644110JEDMEDJEDMED INSTRUMENT COMPANYKCA2020-09-01
M63341644120JEDMEDJEDMED INSTRUMENT COMPANYKCA2020-09-01
M63341644130JEDMEDJEDMED INSTRUMENT COMPANYKCA2020-09-01
04038653180226AESCULAPAesculap AGKCA2020-06-17
04038653180233AESCULAPAesculap AGKCA2020-06-17
04038653180240AESCULAPAesculap AGKCA2020-04-23
04038653180257AESCULAPAesculap AGKCA2020-04-23
24026704507515PILLINGTELEFLEX INCORPORATEDKCA2018-09-15
24026704507522PILLINGTELEFLEX INCORPORATEDKCA2018-09-15
24026704507539PILLINGTELEFLEX INCORPORATEDKCA2018-09-15