FDA.report

N/A

Primary DI
B089B676210
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B67621
Catalog number
B67621
Device description
CASTROVIEJO CALIPER; 200MM, FOR BREAST
Published
2022-09-12
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
HOECaliper, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HOECaliper, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B089B676210PrimaryHIBCC0

GMDN Terms

TermDefinition
General-purpose calliper, metallicA manually-operated metallic device with an analogue Vernier scale designed to make accurate measurements of a patient's anatomy, or of other objects, during surgery, autopsy, or in other clinical settings. It is intended to make external measurements (e.g., external diameter, thickness), internal measurements (e.g., internal diameter, depth), measure length, or make step measurements (i.e., from a larger edge to a lesser edge on an object). It is typically made of stainless steel or chrome-plated steel and can be sterilized in a steam sterilizer (an autoclave). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(770)414-4880info@blackandblacksurgical.com

Regulatory Flags

DUNS number
004382282
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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