FDA.report

Braunstein Fixed Caliper (3.0mm-3.5mm), Stainless Steel

Primary DI
08175700106535
Brand
Braunstein Fixed Caliper (3.0mm-3.5mm), Stainless Steel
Company
AURORA SURGICAL, LLC
Model
AS2-004S
Catalog number
AS2-004S
Device description
Braunstein Fixed Caliper (3.0mm-3.5mm), Stainless Steel
Published
2022-11-14
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

Product Codes

CodeName
HOECaliper, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HOECaliper, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08175700106535PrimaryGS10

GMDN Terms

TermDefinition
Medical ruler, reusableA small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be an independent bendable strip applied to measured surfaces or a strip incorporated into a form convenient for measuring specific devices (e.g., screws). It is not dedicated to wound measurements. 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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