FDA.report

Bausch + Lomb

Primary DI
00757770434282
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
N1772
Catalog number
N1772
Device description
HOOK INCUS ALLPORT
Published
2024-11-20
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

Product Codes

CodeName
JYLHook, Microsurgical Ear

Product Code Classifications

CodeDeviceSpecialtyClass
JYLHook, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00757770434282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770434282007577704342827577704342820757770434282

GMDN Terms

TermDefinition
Bone hookA hand-held, surgical instrument used for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. It is a shaft-like instrument with a robust design and can have a singular hook or multiple hooks at the distal end and a handle of various designs at the proximal end. It is made of high-grade stainless steel. It is sometimes called a bone retractor. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
196603781
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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00310119041024Bausch + Lomb623890FCP-4278A2026-01-09
00310119041062Bausch + Lomb623995FCP-43732026-01-09
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00310119041420Bausch + Lomb623994FCP-43732026-01-09

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