FDA UDI In Commercial Distribution 🇺🇸 United States

GT TUNNELER KIT

DI: 08051122040995 · Model: GTTN00M1-KF · NCS LAB SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
GT TUNNELER KIT
Primary DI
08051122040995
Version / Model
GTTN00M1-KF
Company Name
NCS LAB SRL
Labeler DUNS
429763668
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-06-03
Public Version
1
Public Version Date
2022-06-13
Public Version Status
New
Public Device Record Key
200fb7c2-072c-4e86-9e7c-960471857eda

Device Description

GT TUNNELER device and non-adsorbable sutures.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
LXH Orthopedic Manual Surgical Instrument

GMDN Terms

Code Name
44052 Orthopaedic surgical procedure kit, non-medicated, single-use

Identifiers

Type ID
Primary 08051122040995