FDA.report

Depth Probe

Primary DI
07290109741048
Brand
Depth Probe
Company
BHI IMPLANTS LTD
Model
1
Catalog number
BH-2100
Device description
Implant Site & Gingival Measuring Tool
Published
2016-06-30
Public version status
Update
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290109741048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290109741048072901097410487290109741048

GMDN Terms

TermDefinition
Dental implant/prosthesis surgical procedure kitA collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+972046094458info@bh-implants.com

Regulatory Flags

DUNS number
600330916
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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