FDA.report

Novo Surgical Inc.

Primary DI
00842331135231
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
OP7116-06
Catalog number
OP7116-06
Device description
jaeger lid plate, 21.0 mm & 24.0 mm wide ends, 4 1/4" (10.8 cm)
Published
2022-11-10
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
true

Related Records

Contact Domains

Product Codes

CodeName
HNIRetractor, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNIRetractor, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842331135231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331135231008423311352318423311352310842331135231

GMDN Terms

TermDefinition
Corneoscleral punchA hand-held, manual ophthalmic surgical instrument designed to excise a segment of tissue (frequently in the form of a disc) from the sclera or cornea of a patient or from grafts taken from cadaver donors. It typically has a set of sharp, hollow tips at the distal end (a rotary mechanism that may be either integral or an attachment) operated by squeezing a two-part handle. The device is used mainly to perform ophthalmic graft implantations or, less frequently, to obtain grafts from the sclera of cadaver donors. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1877-860-6686info@novosurgical.com

Regulatory Flags

DUNS number
033029433
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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