FDA UDI In Commercial Distribution 🇺🇸 United States

R.T.R Membrane

DI: 03760140703601 · Model: 9625M · SEPTODONT, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
R.T.R Membrane
Primary DI
03760140703601
Version / Model
9625M
Company Name
SEPTODONT, INC
Labeler DUNS
012925513
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-07-14
Public Version
7
Public Version Date
2023-12-18
Public Version Status
Update
Public Device Record Key
795a74fe-92c7-4704-8276-0f86d4cb178f

Device Description

Absorbable Collagen Membrane (15X20MM) for dental surgery.

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
No
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
LYC Bone Grafting Material, Synthetic

GMDN Terms

Code Name
58740 Dental/maxillofacial soft-tissue biomatrix implant, animal-derived

Identifiers

Type ID
Package 13760140703608
Primary 03760140703601