FDA.report

Ambler Surgical

Primary DI
00190660036744
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Flieringa fixation ring set
Catalog number
5408E
Device description
Flieringa fixation ring set, 16 sizes include - 9.0mm, 10.0mm, 11.0mm, 12.0mm, 13.0mm, 14.0mm, 15.0mm, 16.0mm, 17.0mm, 18.0mm, 19.0mm, 20.0mm, 21.0mm, 22.0mm, 23.0mm and 24.0mm diameters (5409E, 5410E, 5411E, 5412E, 5413E, 5414E, 5415E, 5416E, 5417E, 5418E, 5419E, 5420E, 5421E, 5422E, 5423E and 5424E)
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
HNHRING, OPHTHALMIC (FLIERINGA)

Product Code Classifications

CodeDeviceSpecialtyClass
HNHRing, Ophthalmic (Flieringa)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660036744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660036744001906600367441906600367440190660036744

GMDN Terms

TermDefinition
Scleral marker, reusableA manual instrument intended to be used to indent or imprint the surface of the sclera during an ophthalmic surgical or perioperative procedure. It is typically a hand-held instrument or a thimble-like device (placed on the end of a finger) and is made of metal (e.g., high-grade stainless steel). Various types are available, including the Gass scleral marker that creates a minuscule indentation, the Awh scleral marker that creates parallel scored lines, and the Awh horseshoe design. The device is typically used for retinal detachment surgery. 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
true
Premarket exempt
true
HCT/P
false
Kit
true
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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