FDA.report

Ambler Surgical

Primary DI
00190660127367
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Harms trabeculotome probe
Catalog number
5273E
Device description
Harms trabeculotome probe, 1 5/8'', right, 9.0mm long pointed tips with 3.0mm spread, 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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HNKProbe, trabeculotomy

Product Code Classifications

CodeDeviceSpecialtyClass
HNKProbe, TrabeculotomyOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660127367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660127367001906601273671906601273670190660127367

GMDN Terms

TermDefinition
Lacrimal dilator, reusableA hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. 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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