FDA UDI Not in Commercial Distribution 🇺🇸 United States

Octylbond

DI: 00854137001191 · Model: M1201 · CHEMENCE MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Octylbond
Primary DI
00854137001191
Version / Model
M1201
Catalog Number
M1201
Company Name
CHEMENCE MEDICAL PRODUCTS, INC.
Labeler DUNS
079163089
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-10-18
Public Version
3
Public Version Date
2024-01-10
Public Version Status
Update
Public Device Record Key
3c236c4b-3a37-41f0-bd66-1d12925de7a2
Distribution End Date
2024-01-09

Device Description

Topical Tissue Adhesive

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
Yes
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
MPN Tissue Adhesive For The Topical Approximation Of Skin

GMDN Terms

Code Name
34164 Skin-approximation adhesive

Identifiers

Type ID
Package 20854137001195
Package 10854137001198
Primary 00854137001191

Customer Contacts

Phone
844-633-6583

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
– 86 Degrees Fahrenheit