FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: 07630031774316 · Model: surgically Invasive Instruments · Institut Straumann AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NA
Primary DI
07630031774316
Version / Model
surgically Invasive Instruments
Catalog Number
044.781S
Company Name
Institut Straumann AG
Labeler DUNS
483599259
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-12-02
Public Version
1
Public Version Date
2025-12-10
Public Version Status
New
Public Device Record Key
3d7f1c7a-6c4b-4169-ad95-aefecb176d2c

Device Description

Explantation Drill, long, for Ø 3.5 - 3.75mm, L 42mm, stainless steel

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
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
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
NDP Accessories, implant, dental, endosseous

GMDN Terms

Code Name
66481 Dental implant reamer

Identifiers

Type ID
Primary 07630031774316

Customer Contacts

Device Sizes

Type Value Unit Text
Outer Diameter 3.75 Millimeter
Outer Diameter 3.5 Millimeter
Length 42 Millimeter