DEVICE: G7 STRAIGHT MODULAR SCREWDRIVER (00880304926912)
Device Identifier (DI) Information
G7 STRAIGHT MODULAR SCREWDRIVER
010002749
In Commercial Distribution
010002749
Biomet Orthopedics, LLC
010002749
In Commercial Distribution
010002749
Biomet Orthopedics, LLC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
33968 | Surgical screwdriver, reusable |
A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PBI | prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive |
KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
OQI | Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented |
OQH | Hip, semi-constrained, cemented, metal/polymer + additive, cemented |
OQG | Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented |
JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
LWZ | TISSUE GRAFT OF LESS THAN 6MM |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K121874 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 3.5MM |
Device Record Status
20247817-ae86-4e6c-a967-2b4ba88746eb
May 30, 2025
7
September 22, 2016
May 30, 2025
7
September 22, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)348-9500
customerservice@zimmerbiomet.com
customerservice@zimmerbiomet.com