FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660128425
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Keyes dermal punch
Catalog number
67-408
Device description
Keyes dermal punch, 4'', 8.0mm diameter, round handle
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
LRYPUNCH, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRYPunch, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660128425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660128425001906601284251906601284250190660128425

GMDN Terms#

Term, Definition table
TermDefinition
Paranasal sinus trephineAn ear/nose/throat (ENT) surgical blade designed to cut and remove circular sections of bone or mucous membrane from the paranasal sinuses. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. 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
04063574200203nexoderm® Biopsy Punch Ø 2,0 mmsfm medical devices GmbHLRY2026-09-21
B382SD441309197120Surgical DirectSurgical Direct, Inc.LRY2026-08-03
03701089526586AMPLITUDEAMPLITUDE SASLRY2026-07-29
03701089527187AMPLITUDEAMPLITUDE SASLRY2026-07-29
03701089527194AMPLITUDEAMPLITUDE SASLRY2026-07-29
B382SD323690Surgical DirectSurgical Direct, Inc.LRY2026-07-28
B382SD323790Surgical DirectSurgical Direct, Inc.LRY2026-07-28
B8035903160ORTHOMEDORTHO-MED, INC.LRY2026-07-22
B8034800100ORTHOMEDORTHO-MED, INC.LRY2026-07-14
04946329039580Kerrison Rongeur 150 x 2 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039597Kerrison Rongeur 150 x 3 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039603Kerrison Rongeur 150 x 4 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039610Kerrison Rongeur 150 x 5 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039627Kerrison Rongeur 180 x 3 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039634Kerrison Rongeur 180 x 4 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039641Kerrison Rongeur 180 x 5 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039658Kerrison Rongeur 180 x 1 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
00846338005801KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005818KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005825KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005832KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005849KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005856KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005870KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005887KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005894KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005900KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005924KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005931KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005948KerrisonELLIQUENCE, LLCLRY2026-06-02