FDA.report

NA

Primary DI
00840085202155
Brand
NA
Company
HYHTE HOLDINGS, INC.
Model
GZD100020
Catalog number
GZD100020
Device description
FIXED ANGLE DRILL, BIT
Published
2021-07-16
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
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840085202155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840085202155008400852021558400852021550840085202155

GMDN Terms

TermDefinition
Biopsy drill bitA shaft of metal designed to excise (cut out) a small section of bone or cartilage for microscopic examination. It is mounted into a surgical drilling device, either manual or powered, and when rotated at an appropriate speed will perform the required operation. This is a reusable device.

Device Sizes

TypeValueUnit
Length20Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
7608148047PARKER@ASTURAMEDICAL.COM

Regulatory Flags

DUNS number
073029645
Device count
1
DM exempt
false
Premarket exempt
false
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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