FDA.report

Ambler Surgical

Primary DI
00190660201647
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Golf club foreign body spud
Catalog number
3461E
Device description
Golf club foreign body spud, 4 3/4'', angled, lightly rounded tip with sharp edge, flat 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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HNASpud, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNASpud, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660201647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660201647001906602016471906602016470190660201647

GMDN Terms

TermDefinition
Eye spudA hand-held, manual, ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe. It is typically made of high-grade stainless steel, and designed with a fine handle at the proximal end and a thin concave blade with a rounded nose at the distal end. The ophthalmologist uses this tip to remove the foreign body/object. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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