FDA.report

Tenotomy Scissors

Primary DI
08175700147019
Brand
Tenotomy Scissors
Company
AURORA SURGICAL, LLC
Model
AS12-051
Catalog number
AS12-051
Device description
Westcott Curved Tenotomy Scissors, Blunt Tips, 16mm Blades, Flat Hdl
Published
2023-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HNFScissors, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08175700147019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08175700147019081757001470198175700147019

GMDN Terms

TermDefinition
Conjunctival scissors, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used to cut the conjunctiva and Tenon’s capsule on the eye surface to access the sclera. It comprises two pivoted blades which cut with a shearing action directly adjacent to the handles (thumb ring-handles or tweezers-like handles). It is typically made of metal and is available in various designs and sizes. It may additionally be used for cutting sutures and/or drapes, however, it is neither intended for intraocular surgery nor for other extraocular surgeries. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
7278213303info@aurorasurgical.com

Regulatory Flags

DUNS number
968368832
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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08175700157001PunchesAS14-300AS14-3002024-03-11
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08175700157032PunchesAS14-303AS14-3032024-03-11
08175700157049PunchesAS14-304AS14-3042024-03-11
08175700157506PunchesAS14-305AS14-3052024-03-11
08175700157513PunchesAS14-306AS14-3062024-03-11
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08175700155670ProbesAS14-001TAS14-001T2024-02-06
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