FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660023904
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Ray pituitary curette
Catalog number
19-692
Device description
Ray pituitary curette, 7 1/2'', angled horizontal 45 degrees, 4.0mm diameter, round handle
Published
2021-01-07
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
HAOINSTRUMENT, SURGICAL, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660023904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660023904001906600239041906600239040190660023904

GMDN Terms#

Term, Definition table
TermDefinition
Endaural curette, reusableA slender, hand-held, manual surgical instrument designed for scraping within the ear canal (e.g., removing wax), and during middle ear surgery (e.g., removal of the superior bony rim). The instrument has a serrated or blunt loop, or hook, at its distal end that may be straight, slightly curved, or angled; it 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
DM exempt
false
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

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Primary DI, Brand, Company table
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04058749068481NAFehling Instruments GmbH & Co. KGHAO2026-01-28
04058749076110NAFehling Instruments GmbH & Co. KGHAO2026-01-28
04058749076349NAFehling Instruments GmbH & Co. KGHAO2026-01-28
00810123209750Adler Instrument CompanyAdler, Inc.HAO2026-01-02
00810123209767Adler Instrument CompanyAdler, Inc.HAO2026-01-02
00873263009321Visualase Anchor Bolt ToolsFHC, INC.HAO2025-12-12
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00873263009352Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
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00873263009383Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
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00873263009406Visualase Anchor Bolt Removal ToolFHC, INC.HAO2025-12-12
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04058749076059NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749082517NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749082562NAFehling Instruments GmbH & Co. KGHAO2025-12-08