FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660000165
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
LaForce/Shambaugh replacement adenotome blade
Catalog number
10-163
Device description
LaForce/Shambaugh replacement adenotome blade, medium size, 16.0mm wide
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
KBHADENOTOME

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660000165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660000165001906600001651906600001650190660000165

GMDN Terms#

Term, Definition table
TermDefinition
Adenoid curette, reusableA hand-held manual surgical instrument designed for cutting and excising adenoid tissue (hypertrophic lymphoid tissue in the nasopharynx) during an adenoidectomy (adenectomy). It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge that is used to facilitate the removal of the tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the adenoids. 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
00757770420322Bausch + LombBausch & Lomb IncorporatedKBH2025-07-29
00757770424443Bausch + LombBausch & Lomb IncorporatedKBH2025-07-29
00757770429974Bausch + LombBausch & Lomb IncorporatedKBH2025-07-29
00757770430055Bausch + LombBausch & Lomb IncorporatedKBH2025-07-29
00190776381943MillenniumAvalign Technologies, Inc.KBH2024-04-30
G586E8221210Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221220Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221230Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221240Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221720Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221730Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221740Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
00190776352721MillenniumAvalign Technologies, Inc.KBH2023-11-17
00190776049430AvalignAvalign Technologies, Inc.KBH2023-09-28
00190776227999AvalignAvalign Technologies, Inc.KBH2023-09-28
00190776228002AvalignAvalign Technologies, Inc.KBH2023-09-28
00190776228019AvalignAvalign Technologies, Inc.KBH2023-09-28
00190776327194MillenniumAvalign Technologies, Inc.KBH2023-06-23
G22313594910Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKBH2023-06-08
00887482192825Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBH2022-12-08
00887482192832Symmetry ASPEN SURGICAL PRODUCTS, INC.KBH2022-12-08
00842331170294Novo Surgical Inc. NOVO SURGICAL, INC.KBH2022-11-13
00190660000103Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000110Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000127Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000134Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000141Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000158Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000172Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000189Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04