FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660039448
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Antrum punch forceps
Catalog number
26-149
Device description
Antrum punch forceps, 8 1/4'', working length 140mm, 90 degrees up cutting, 4.0mm x 5.0mm bite
Published
2021-01-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTFPUNCH, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTFPunch, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660039448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660039448001906600394481906600394480190660039448

GMDN Terms#

Term, Definition table
TermDefinition
Adenoid punch forcepsA hand-held manual surgical instrument with a cutting/biting action intended to be used for excising adenoid tissue (hypertrophic lymphoid tissue in the nasopharynx) during an adenoidectomy (adenectomy). It is a metallic alligator-forceps-like instrument, often with a curved shaft, and with a distal mechanism designed to bite/punch adenoid tissue when the handles are squeezed together. It is not intended for cutting bone (i.e., not a rongeur). 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
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04054462915163evonosevonos GmbH & Co. KGKTF2026-08-17
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04054462915187evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915194evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915200evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915217evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915224evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915231evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915248evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915255evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915262evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915279evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915286evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915293evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915309evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915316evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915323evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915347evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915354evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915361evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915378evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915385evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915392evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915408evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915415evonosevonos GmbH & Co. KGKTF2026-08-17